The goal of this clinical trial is to learn the efficacy of cardiovascular ultrasound therapy on the rehabilitation of patients with coronary heart disease after PCI. It will also learn about the safety of cardiovascular ultrasound. The main questions it aims to answer are: Whether cardiovascular ultrasound improves cardiac function and prognosis in patients with coronary artery disease after PCI? What medical problems will participants experience after using cardiovascular ultrasound therapy? Researchers will compare cardiovascular ultrasound to a placebo (sham stimulation) to see if cardiovascular ultrasound works to treat coronary artery disease after PCI. Participants will: Patients were treated with cardiovascular ultrasound or placebo from the 24th hour after PCI for 20 minutes twice a day for 10 days. Examination and detection of serum inflammatory markers, endothelial function indicators, cardiac function, and heart rate variability at multiple time points (baseline (24 hours post-PCI), days 5 and 10 post-intervention, and months 1 and 3. Their symptoms were recorded, and depression and anxiety were scored.
Background Coronary heart disease (CHD) is one of the leading causes of mortality and disability and places a financial burden on the healthcare system. Although cardiovascular ultrasound has shown its effectiveness and safety in improving refractory angina, relevant clinical studies are rare, and clinical evidence is severely lacking. Methods and design This is a prospective, parallel-group, randomized control trial. We will enroll 200 patients with coronary artery disease after PCI and randomize them into 2 groups. The intervention group was given usual practice combined with cardiovascular ultrasound intervention and the control group was given usual practice combined with empty stimulation intervention. We used hs-CRP and IL-6 levels in serum after 20 times treatments with LIPUS as the primary outcome measures. Serum myocardial injury indicators levels and blood lipids indicators levels, markers of endothelial function levels, inflammatory factor levels, hemodynamic Indicators, Echocardiogram, 6-minute walk test, Short-term Heart rate variability, and mental health assessment were secondary outcomes. The researchers tested the outcome indicators at baseline (24th hours after PCI), 5th and 10th days, and 1st and 3rd months after the intervention. Statistical analyses were performed using SPSS 26.0 statistical software. Discussion This study is the first clinical study of the rehabilitation efficacy of cardiovascular ultrasound in the treatment of coronary heart disease after PCI. Given that the current clinical recovery mainly depends on the body's self-limiting and conventional symptomatic treatment, Cardiovascular ultrasound, as a new therapy method, might be a major advance in the treatment of coronary heart disease after PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Participants in the intervention group will be treated with a medical LIPUS device (838C-M-L-I/II, Shenzhen, China) for 10 days in addition to conventional medical treatment. The ultrasound therapy instrument is equipped with a sound head comprising 5 transducer units, operating at an ultrasonic frequency of 0.84MHz with a sound intensity range of 1 W/cm2 -1.25 W/cm2. The therapeutic ultrasound sessions necessitate a controlled environmental temperature. Patients will assume the supine position, exposing the precordial region, with the five-pronged head positioned parallel to the heart\'s long axis, covering the entire precordial region including the right and left coronary arterial trunks and the aortic root. The ultrasound therapy device operates in a pulsed mode, with each treatment session lasting 20 minutes, comprising 2 daily sessions for a total of 20 treatments.
Qilu Hospital of Shandong University
Jinnan, Shandong, China
high-sensitivity C-reactive protein (hs-CRP) in serum
High-sensitivity C-reactive protein (hs-CRP) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions.
Time frame: Day 11 after PCI
Interleukin-6 (IL-6) levels
high-sensitivity C-reactive protein (hs-CRP) and Interleukin-6 (IL-6) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions
Time frame: Day 11 after PCI
creatine kinase isoenzymes
Serum creatine kinase isoenzyme levels in fasting were collected and measured
Time frame: From enrollment to the end of treatment at 3rd month
cardiac troponin I
Serum cardiac troponin I levels in fasting were collected and measured
Time frame: From enrollment to the end of treatment at 3rd month
myeloperoxidase
Serum myeloperoxidase levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
total cholesterol
Serum total cholesterol levels in fasting were collected and measured
Time frame: From enrollment to the end of treatment at 3rd month
triglyceride
Serum triglyceride levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
low-density lipoprotein cholesterol
Serum low-density lipoprotein cholesterol levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
high-density lipoprotein cholesterol
Serum high-density lipoprotein cholesterol levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
apolipoprotein A
Serum apolipoprotein A levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
apolipoprotein B
Serum apolipoprotein B levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
lipoprotein (a)
Serum lipoprotein (a) levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
oxidized low-density lipoprotein
Serum-oxidized low-density lipoprotein levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
endothelial nitric oxide synthase
Serum endothelial nitric oxide synthase levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
endothelin-1
Serum endothelin-1 levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
vascular endothelial growth factor
Serum vascular endothelial growth factor levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
procalcitonin
Serum procalcitonin levels in fasting were collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Systemic Vascular Resistance
Stroke Systemic Vascular Resistance Index was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Mean Arterial Pressure
Mean Arterial Pressure was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Stroke Volume Index
Stroke Volume Index was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Stroke Volume
Stroke Volume levels was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Cardiac Output
Cardiac Output was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Cardiac Index
The Cardiac Index was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Left Ventricular Stroke Work Index
The left Ventricular Stroke Work Index was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Systemic Vascular Resistance Index
The systemic Vascular Resistance Index was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Ejection Phase Contraction Index
Ejection Phase Contraction Index was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Inotropic State Index
Inotropic State Index was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Systemic Vascular Resistance
Systemic Vascular Resistance was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Vascular Resistance
Vascular Resistance was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Mean Heart Rate
Mean Heart Rate was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
left ventricular ejection fraction
left ventricular ejection fraction was collected and measured
Time frame: From enrollment to the end of treatment at 3rd month
Wall thickening fraction
Wall thickening fraction was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
E/E'
E/E\' was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
6-minute walk test
A 6-minute walk test was collected and measured.
Time frame: From enrollment to the end of treatment at 3rd month
Patient Health Questionnaire-9
Patient Health Questionnaire-9 was scored and collected. The Patient Health Questionnaire-9 (PHQ-9) serves as a critical instrument for the screening, diagnosis, and assessment of depression, enabling the measurement of its severity.
Time frame: From enrollment to the end of treatment at 3rd month
7-item Generalized Anxiety Disorder Scale
A 7-item Generalized Anxiety Disorder Scale (GAD-7) was scored and collected. GAD-7 acts as an essential tool for evaluating generalized anxiety disorder
Time frame: From enrollment to the end of treatment at 3rd month
The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI)was scored and collected. the Pittsburgh Sleep Quality Index (PSQI) stands as a widely recognized assessment tool for determining sleep quality.
Time frame: From enrollment to the end of treatment at 3rd month
Seattle Angina Questionnaire (SAQ)
The Seattle Angina Questionnaire (SAQ) was scored and collected. SAQ functions as a self-administered assessment tool designed to evaluate specific functional status and quality of life among individuals with coronary artery disease.
Time frame: From enrollment to the end of treatment at 3rd month
Heart rate variability
Heart rate variability was scored and collected. Heart rate variability (HRV) refers to the fluctuation in the timing of consecutive heartbeats or the variance in heart rate. It is determined by the duration between two successive R-R intervals, representing the slight deviation between each cardiac cycle. HRV assessment was conducted using the ZSY-1 Rhythm Variability Analyzer, with the patient in a supine position, and short-term (5-minute) HRV was measured during daytime hours (8:00-16:00) while at rest.
Time frame: From enrollment to the end of treatment at 3rd month
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