This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
This is a prospective, multicenter, randomized controlled clinical trial that will evaluate the effectiveness and safety of the CardioGard embolic protection cannula compared to a standard cannula. The enrollment period is expected to last 30 months, and all patients will be followed for 12 months post procedure. RANDOMIZATION Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the operating room (OR) immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device). Randomization will be with equal allocation and stratified by site and by procedure (i.e., isolated valve surgery or combined procedures, such as double valve or valve plus coronary artery bypass grafting, CABG). The randomization assignment will be controlled centrally and performed through a web-based data collection system that automates the delivery of the randomization codes. From the point of treatment assignment, primary efficacy will be analyzed by intention-to-treat; that is, the patients will be grouped by their assignments at randomization regardless of whether or not they actually received the treatment to which they were assigned. STUDY POPULATION The patient population for this trial consists of patients age ≥ 60 undergoing different types of valve surgery with or without CABG via full or minimal-access sternotomy using legally marketed valve(s). Specific inclusion and exclusion criteria are listed below. All patients who meet the eligibility criteria may be included in the study regardless of gender, race, or ethnicity. SUBSTUDY Sleep Disturbance Ancillary Sub-Study - Patients undergoing surgery for valvular heart disease (VHD) are at high risk for adverse events, including high rates of post-operative delirium (POD). Should circadian disruption be found to be an important predictor in this high-risk population, safe, low cost, and easy to administer therapies to regulate circadian rhythm such as light therapy could be evaluated in future studies The aims of this ancillary sub-study include: 1. To investigate the association between short sleep duration, less sleep regularity, and greater circadian rhythm disruption prior to surgery and POD within 7 days of VHD surgery. 2. To investigate the association between short sleep duration, less sleep regularity and greater circadian rhythm disruption (reduced melatonin and cortisol amplitudes) after surgery and POD within 7 days of VHD surgery. Approximately 300 EMPRO trial participants will be enrolled into the ancillary study. The study is being conducted in highly experienced clinical centers in the U.S. and Canada. The estimated enrollment period is 12-15 months. All eligible and consented patients in the parent EMPRO trial will be offered enrollment in this ancillary study through the parent trial consent process.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
842
The CardioGard embolic protection cannula is a device that combines the function of a standard aortic cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The device is comprised of 2 hollow tubes. The first tube is the standard main forward-flow tube to return oxygenated blood to the patient's aorta. The second tube attached to an existing bypass vent port, is a novel element located posteriorly to the main tube; its function is to facilitate blood and particle suction by directing the blood back to the reservoir of the coronary bypass machine, while the retrieved embolic debris is eliminated through the filter of the venous reservoir.
An aortic cannula is a device that is used routinely during cardiac surgery to return oxygenated blood from the cardiac bypass machine into the patient's aorta.
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
The combined number of patients who experience clinical ischemic strokes and acute kidney injuries that have occurred within 3 days post-randomization.
Time frame: within 3 days post-randomization
Number of patients who experience of death and delirium
The combined number of patients who experience death and delirium by 7 days post-randomization (with a blanking period for delirium of days 1 and 2 post-operatively).
Time frame: by 7 days post-randomization
Proportion of patients who experience a clinical ischemic stroke
The proportion of patients who experience a clinical ischemic stroke within 3 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
Time frame: within 3 days post-randomization
Proportion of patients who experience a clinical ischemic stroke
The proportion of patients who experience a clinical ischemic stroke within 7 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
Time frame: within 7 days post-randomization
Number of patients with disabling clinical stroke
Number of patients with disabling clinical stroke within 3 days post-randomization
Time frame: within 3 days post-randomization
Number of patients with disabling clinical stroke
Number of patients with disabling clinical stroke within 7 days post-randomization
Time frame: within 7 days post-randomization
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CHI St. Vincent Heart Institute
North Little Rock, Arkansas, United States
RECRUITINGKeck Hospital of the University of Southern California
Los Angeles, California, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGIndiana University
Bloomington, Indiana, United States
WITHDRAWNIndiana Ohio Heart
Fort Wayne, Indiana, United States
WITHDRAWNOchsner Clinic
New Orleans, Louisiana, United States
RECRUITINGMaine Medical Center
Portland, Maine, United States
RECRUITINGJohns Hopkins Medicine
Baltimore, Maryland, United States
RECRUITINGUniversity of Maryland
College Park, Maryland, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITING...and 18 more locations
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery. Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment. These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
Time frame: within 3 days post-randomization
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery. Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment. These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
Time frame: within 7 days post-randomization
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at baseline days. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3\. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Time frame: at baseline
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 30 days. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3\. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Time frame: at 30 days
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 90 days. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3\. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Time frame: at 90 days
Montreal Cognitive Assessment (MoCA) Score
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at presurgical baseline. The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.
Time frame: at baseline
Montreal Cognitive Assessment (MoCA) Score
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 90 days. The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
Time frame: at 90 days
Montreal Cognitive Assessment (MoCA) Score
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 12 months. The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
Time frame: at 12 months
Oral Trail Making Test - Parts A and B (executive function)
The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Time frame: at baseline
Oral Trail Making Test - Parts A and B (executive function)
The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Time frame: at 90 days post-randomization
Oral Trail Making Test - Parts A and B (executive function)
The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Time frame: at 12 months post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Time frame: baseline
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Time frame: at 90 days post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Time frame: at 12 months post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Symbol Substitution Test (processing speed)
The WAIS-R Digit Symbol Substitution Test (DSST) is a paper-and-pencil cognitive test that consist of number-symbol pairs. It requires the examinee to copy, into spaces below rows of numbers, the symbols that are paired to each number. The DSST score is the number of digits coded correctly in a 90-second test period
Time frame: at baseline
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Time frame: at baseline
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Time frame: at 90 days post-randomization
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Time frame: at 12 months post-randomization
Incidence of Delirium
The incidence of delirium will be assessed daily by the Confusion Assessment Method (3D-CAM or CAM-ICU) scale, or by the presence of a delirium adverse event, during the first 7 days post-randomization. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4 and involves the presence/absence of delirium, but not its severity. Any error or behavioral observation consistent with a delirium feature means that feature is present.
Time frame: first 7 days post-randomization
Duration of Delirium
The duration of delirium will be measured as the number of days with positive CAM assessments or delirium adverse events by 7 days post-randomization. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Time frame: first 7 days post-randomization
Severity of Delirium
The severity of delirium will be measured during daily screening using standardized algorithms for extracting symptom severity from the 3D-CAM and CAM-ICU.
Time frame: first 7 days post-randomization
Number of Patients who experience Acute kidney injury (AKI)
Number of Patients who experience Acute kidney injury will be assessed within 7 days post-randomization.
Time frame: within -7 days post-randomization
All-cause mortality
All-cause mortality within 90 days post-randomization will be assessed.
Time frame: within 90 days post-randomization
All-cause mortality
All-cause mortality within 12-months post-randomization will be assessed.
Time frame: within 12 months post-randomization
Length of Index Hospitalization
Overall length of stay for the index hospitalization post-randomization will be measured and broken down by days spent in the ICU versus days not in the ICU.
Time frame: at hospital discharge, up to 30 days
Discharge disposition
Discharge disposition
Time frame: at hospital discharge, up to 30 days
Readmissions rates
Readmission rates will be calculated for the first 90 days following randomization. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
Time frame: first 90 days
Readmissions rates
Readmission rates will be calculated for the duration of follow-up, out to 1 year. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
Time frame: up to 1 year post-randomization
Days Alive out of Hospital
Days alive out of hospital and nursing/rehab facilities within 90 days after randomization
Time frame: within 90 days post-randomization
Actigraphy
Actigraphy data will be collected for a period of 7 days prior to the index surgical procedure. Actigraphic monitoring employs an accelerometer the size of a watch, which each study patient will wear on the wrist. Collected for participants in substudy.
Time frame: 7-day period prior to index surgical procedure and Day 1 post index surgical procedure through hospital discharge
Amount of Circadian Light
A Speck light meter will be worn as a pendant while awake for a period of 7 days prior to surgery. Light measurements from light meters used as pendants are the closest to light measurements at eye level. The light meter will also be used to monitor the total amount of circadian light received by the patient. Collected for participants in substudy.
Time frame: 7-day period prior to index surgical procedure
Photopic Light Levels
A Speck light meter will be worn as a pendant while awake for a period of 7 days prior to surgery. Light measurements from light meters used as pendants are the closest to light measurements at eye level. The light meter will also be used to calculate photopic light levels Collected for participants in substudy.
Time frame: 7-day period prior to index surgical procedure
Circadian Stimulus Values
A Speck light meter will be worn as a pendant while awake for a period of 7 days prior to surgery. Light measurements from light meters used as pendants are the closest to light measurements at eye level. The light meter will also be used to calculate circadian stimulus values, Collected for participants in substudy.
Time frame: 7-day period prior to index surgical procedure
Richards-Campbell Sleep Questionnaire
Patients who are able to do so will be asked to fill out the Richards-Campbell Sleep Questionnaire (RCSQ), which is a brief 2-minute questionnaire designed for patient use in the ICU. Full score range from 0-100, with higher score indicating better sleep. Collected for participants in substudy.
Time frame: Day 1 post index surgical procedure through patient discharge from the ICU (average ICU stay is 3 days)