The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention with stent placement after ST segment elevation MI (STEMI).
Heart failure is a significant problem, and carries substantial mortality. According to studies, left ventricular (LV) remodeling contributes independently to heart failure progression. Prevention and reversal of LV remodeling are correlated with decreased risk of death and heart failure events. IK-5001 is an implantable device to be used in subjects with recent myocardial infarction (MI). The IK-5001 device has been shown to directly halt the remodeling process that occurs following acute MI. IK-5001 replaces the damaged extracellular matrix (ECM) that has degraded during infarction, supports the damaged myocardial tissue, prevents local dyskinesis, and decreases wall stress. Because of its minimal interaction with the myocardium, its mechanism of action, its lack of specific pharmacologic activity and its elimination behavior, IK-5001 is a medical device in concurrence with the Global Harmonization Task Force's harmonized definition for medical devices.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
303
4 mL (+/- 0.2 mL) administered through intracoronary slow bolus injection over 15 to 30 seconds at least 2 days after PCI but within 5 days of onset of symptoms.
4 mL (+/- 0.2 mL) slow bolus, intracoronary injection of saline solution will be administered over 15 to 30 seconds at least 2 days after percutaneous coronary intervention (PCI) but within 5 days of onset of symptoms.
Left Ventricular End Diastolic Volume Index
Anatomic measurement of left ventricular end diastolic volume index (LVEDVI) assessed through echocardiogram.
Time frame: Baseline, 6 Months
Kansas City Cardiomyopathy Questionaire
Patient reported outcomes (PROs) using The Kansas City Cardiomyopathy Questionaire (KCCQ) score - a validated disease-specific self-administered 23-item questionnaire that will be used to quantify symptoms, function, and quality of life of subjects.
Time frame: Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits
Six minute walk test
The six minute walk test (6MWT) is used for measuring the response to medical interventions in subjects with moderate to severe heart disease, functional status of subjects, as well as a predictor of morbidity and mortality
Time frame: Baseline (prior to discharge STEMI), 1, 3, 6 and 12 month follow-up visits
New York Heart Association (NYHA) functional classification (Physician reported)
New York Heart Association (NYHA) classification assessed by physician will be categorized by Class (Class I - IV)
Time frame: Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits
Cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations
Time to cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations adjudicated by a Clinical Events Committee
Time frame: 5 Years
Re-hospitalization due to any cardiovascular event
Time to re-hospitalization due to any cardiovascular event
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Cardiology, P.C.
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Henry Ford Health System
Detroit, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Stony Brook Medicine
Stony Brook, New York, United States
Montefiore Medical Center Weiler Division
The Bronx, New York, United States
...and 72 more locations
Time frame: 5 Years