IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction

Not Applicable

Completed

Conditions: Acute Myocardial Infarction
Congestive Heart Failure
ST-Elevation Myocardial Infarction

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Left Ventricular End Diastolic Volume Index	Baseline, 6 Months	Anatomic measurement of left ventricular end diastolic volume index (LVEDVI) assessed through echocardiogram.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations	5 Years	Time to cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations adjudicated by a Clinical Events Committee
Kansas City Cardiomyopathy Questionaire	Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits	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.
Six minute walk test	Baseline (prior to discharge STEMI), 1, 3, 6 and 12 month follow-up visits	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
New York Heart Association (NYHA) functional classification (Physician reported)	Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits	New York Heart Association (NYHA) classification assessed by physician will be categorized by Class (Class I - IV)
Re-hospitalization due to any cardiovascular event	5 Years	Time to re-hospitalization due to any cardiovascular event

Locations (82): Cardiology, P.C.
🇺🇸
Birmingham, Alabama, United States
Harbor - UCLA Medical Center
🇺🇸
Torrance, California, United States
MedStar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
University of Miami Hospital
🇺🇸
Miami, Florida, United States
St. Vincent Medical Group Inc.
🇺🇸
Indianapolis, Indiana, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
Minneapolis Heart Institute
🇺🇸
Minneapolis, Minnesota, United States
Montefiore Medical Center Weiler Division
🇺🇸
Bronx, New York, United States
Stony Brook Medicine
🇺🇸
Stony Brook, New York, United States
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Cardiology, P.C.
🇺🇸Birmingham, Alabama, United States