STEMI-MR: Use of Cardiac MRI in Early Stages of STEMI to Predict Left Ventricular Function Recovery and ICD Implantation

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Terminated
CT.gov ID
NCT03743935
Collaborator
Société Française de Cardiologie (Other)
12
1
1
25.5
0.5

Study Details

Study Description

Brief Summary

Patients presenting with STEMI and late revascularization can suffer from severe left ventricular dysfunction. Midterm and longterm mortality can be determined by the risk of fatal ventricular arrythmias. For this specific population, ESC guidelines currently recommend a waiting period of up to 40 days after a STEMI with severe left ventricular dysfunction before considering ICD implantation for primary prevention of sudden death.This delay is allocated to judge left ventricular recovery.

This study aims to see whether early cardiac MRI with specific sequences can help predict which patients will most probably not recover their left ventricular function and benefit from earlier ICD implantation.

Condition or Disease Intervention/Treatment Phase
  • Other: Gadolinium-enhanced cardiac MRI
N/A

Detailed Description

ST segment elevation myocardial infarction represent 120 000 annual cases in France. Although its mortality has been drastically reduced by primary percutaneous coronary angioplasty (PCI), its midterm and longterm outcome in patients presenting initially with severe left ventricular (LV) dysfunction depends on the risks of heart failure and sudden death by malignant ventricular arrhythmias.

Many clinical studies such as MADIT I and II, MUSTT and DINAMIT have participated in defining which patients should benefit from ICD implantation. These studies were based on evaluation of the LV ejection fraction (LVEF) and of the risk of arrhythmia (by electrophysiology or holter recordings).

However, ESC Guidelines recommend a mandatory waiting period of 40 days post-PCI to reevaluate LVEF before confirming the need for ICD implantation (LVEF < 35%). Therefore, patients are at risk of sudden cardiac death (SCD). during this period.

The investigators sought to determine whether specific cardiac MRI sequences could help predict which patients would eventually recover from their LV dysfunction and therefore reduce the risk of SCD by implanting ICD earlier than recommended.

Patients presenting at our Cardiac ICU with STEMI and severe LV dysfunction (LVEF < 35%), not indicated to coronary artery bypass surgery (CABG) and free from initial cardiac arrest or severe ventricular arrhythmias, will be included. They will undergo a gadolinium-enhanced cardiac MRI during the 1st days of hospitalization with specific sequences to determine myocardial zones at risk of non-recovery.

Initial assessment will also include thorough clinical examination with NYHA class, trans-thoracic echocardiography and blood works to evaluate renal function, inflammation, signs of heart failyre (BNP and troponin). Patients will be equipped with Lifevests for 6 weeks and followed-up with the same criteria.

Ratio of final ICD implantation will then be compared to the MRI criterion to determine whether LV recovery could have been predicted.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Primary Prevention ICD Implantation in STEMI With Severe Left Ventricular Dysfunction : Input of Early Cardiac MRI in Order to Predict Left Ventricular Recovery
Actual Study Start Date :
Jan 7, 2019
Actual Primary Completion Date :
Feb 22, 2021
Actual Study Completion Date :
Feb 22, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Early cardiac MRI post-STEMI

Early stages post-STEMI (within the first 5 days)

Other: Gadolinium-enhanced cardiac MRI
Gadolinium-enhanced cardiac MRI during the 1st days post-STEMI with specific sequences including extra-cellular volume measurement

Outcome Measures

Primary Outcome Measures

  1. Mesure of zones of delayed myocardial transmural enhancement and no-reflow [40 days]

    Defining the area at risk with Cardiac MRI

  2. Mesure of ejection fraction and regional wall motion and thickening [40 days]

    Defining the area at risk with Cardiac MRI

  3. Mesure of extracellular volume [40 days]

    Defining the area at risk with Cardiac MRI

Secondary Outcome Measures

  1. Number of CVD events [40 days]

    Occurrence of major adverse cardiac events

  2. Number of admission to the hospital for heart failure event [40 days]

    Occurrence of heart failure events

  3. Number of ischemic cardiovascular events [40 days]

    Occurrence of major adverse cardiac events

  4. Number of cardiac death [40 days]

    Occurrence of major adverse cardiac events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Acute STEMI within 5 last days with LVEF < 35%

  • 18-80 years old

  • Admitted to the Cardiac ICU

  • Consent form

Exclusion Criteria:
  • CABG surgery indicated

  • Contra-indications to MRI

  • ICD or PPM in place

  • Follow-up compromised

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Montpellier Montpellier France 34090

Sponsors and Collaborators

  • University Hospital, Montpellier
  • Société Française de Cardiologie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT03743935
Other Study ID Numbers:
  • UF 7649
First Posted:
Nov 16, 2018
Last Update Posted:
May 16, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2022