Acute Myocardial Infarction Clinical Trial
Official title:
A Placebo Controlled, Multicenter, Randomized Double Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04451967 -
Acute Myocardial Infarction Study in Northeastern China
|
||
| Completed |
NCT05974397 -
Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan
|
||
| Not yet recruiting |
NCT04072081 -
Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions
|
N/A | |
| Recruiting |
NCT03940443 -
Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
|
||
| Recruiting |
NCT03707626 -
Collateral Circulation to LAD and Wellens Sign
|
||
| Completed |
NCT02669810 -
EXCELLENT (EXpanded CELL ENdocardiac Transplantation)
|
Phase 2 | |
| Not yet recruiting |
NCT04104048 -
Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
|
||
| Active, not recruiting |
NCT02915107 -
The SORT OUT IX STEMI OCT Trial
|
N/A | |
| Completed |
NCT02896543 -
The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction
|
N/A | |
| Completed |
NCT02490969 -
Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19
|
N/A | |
| Completed |
NCT02531165 -
Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
|
N/A | |
| Withdrawn |
NCT01901471 -
Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock
|
Phase 2 | |
| Completed |
NCT02312336 -
A Pilot Study of Transcoronary Myocardial Cooling
|
N/A | |
| Recruiting |
NCT02071342 -
Study of ABSORB Stent in Acute Myocardial Infarction
|
N/A | |
| Completed |
NCT02070913 -
COOL-AMI EU Case Series Clinical Study
|
||
| Terminated |
NCT01972126 -
MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction
|
N/A | |
| Completed |
NCT01216995 -
Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)
|
Phase 2 | |
| Completed |
NCT01887080 -
Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program
|
N/A | |
| Withdrawn |
NCT01678339 -
Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients
|
N/A | |
| Completed |
NCT01325116 -
Delayed Educational Reminders in Acute Myocardial Infarction (MI)
|
N/A |