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NCT03725826 · ClinicalTrials.gov registry record
Risk Stratification After Acute Myocardial Infarction With Cardiac MRI
A clinical trial, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- 57
- Enrollment target
NCT03725826: Completed study, sponsored by Montefiore Medical Center.
NCT03725826 is a clinical trial that has completed, run by Montefiore Medical Center. The registered enrollment target is 57 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03725826 has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- 57 participants
- Enrollment target
Study Summary
Given the existing controversy regarding the appropriate determination time for placement of implantable cardioverter-defibrillator (ICD) in patients at risk for sudden cardiac death (SCD) following acute myocardial infarction (AMI), the modest ability of current criteria to determine which patients will experience SCD, and the high impact of SCD to society, we propose to conduct a prospective non-randomized observational study to determine: * Whether quantification of left ventricular (LV) scar volume by cardiac magnetic resonance (CMRI) prior to hospital discharge helps to predict which patients will have a low ejection fraction (35%) at follow up and qualify for ICD implantation. * Whether quantification of infarct scar volume by CMRI will help to identify which patients will experience malignant ventricular arrhythmias and/or SCD at follow-up, independent of the LV ejection fraction (LVEF). Primary hypothesis: Percentage of left ventricular scar volume as measured by CMRI post-MI strongly correlates with LVEF at 40 days and 3 months. Secondary hypothesis: 1. A volume of \>40% of left ventricular scar measured by CMRI post-MI is predictive of LVEF less than 35% at 40 days and at 3 months 2. Volume scar as measured by Cardiac magnetic resonance imaging after AMI (at day 5) is predictive of clinical outcomes: SCD, total mortality, heart failure admission and life-threatening malignant ventricular arrhythmias regardless of ejection fraction at 40 days and at 3 months. Safety hypothesis: ICDs will be implanted if patients meet criteria at 40 days post MI as per the current American College of Cardiology (ACC) /American Heart Association (AHA) /Heart Rhythm Society (HRS) 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities
Primary Outcome
The degree of LVEF recovery after a first MI provides important prognostic information. Patients with no recovery in LVEF after MI are at high risk of sudden cardiac arrest events and death.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-09 |
What the finished NCT03725826 record still lists
NCT03725826 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 57 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03725826 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03725826 about?
NCT03725826 is a clinical study titled "Risk Stratification After Acute Myocardial Infarction With Cardiac MRI". Given the existing controversy regarding the appropriate determination time for placement of implantable cardioverter-defibrillator (ICD) in patients at risk for sudden cardiac death (SCD) following acute myocardial infarction (AMI), the modest ability of current criteria to determine which patients...
What is the current status of trial NCT03725826?
This trial is currently completed. The enrollment target is 57 participants. The study started on 2013-05. Estimated completion is 2016-09.
Who is sponsoring clinical trial NCT03725826?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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