Use of Cardiac MRI in Early Stages of STEMI to Predict Left Ventricular Function Recovery and ICD Implantation (STEMI-MR)
Primary Purpose
Acute STEMI, Severe Left Ventricular Systolic Dysfunction (Disorder)
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Gadolinium-enhanced cardiac MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute STEMI focused on measuring STEMI, MRI, ICD, Sudden death
Eligibility Criteria
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
Sites / Locations
- University Hospital of Montpellier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Early cardiac MRI post-STEMI
Arm Description
Early stages post-STEMI (within the first 5 days)
Outcomes
Primary Outcome Measures
Mesure of zones of delayed myocardial transmural enhancement and no-reflow
Defining the area at risk with Cardiac MRI
Mesure of ejection fraction and regional wall motion and thickening
Defining the area at risk with Cardiac MRI
Mesure of extracellular volume
Defining the area at risk with Cardiac MRI
Secondary Outcome Measures
Number of CVD events
Occurrence of major adverse cardiac events
Number of admission to the hospital for heart failure event
Occurrence of heart failure events
Number of ischemic cardiovascular events
Occurrence of major adverse cardiac events
Number of cardiac death
Occurrence of major adverse cardiac events
Full Information
NCT ID
NCT03743935
First Posted
November 9, 2018
Last Updated
May 13, 2022
Sponsor
University Hospital, Montpellier
Collaborators
Société Française de Cardiologie
1. Study Identification
Unique Protocol Identification Number
NCT03743935
Brief Title
Use of Cardiac MRI in Early Stages of STEMI to Predict Left Ventricular Function Recovery and ICD Implantation
Acronym
STEMI-MR
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Société Française de Cardiologie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute STEMI, Severe Left Ventricular Systolic Dysfunction (Disorder)
Keywords
STEMI, MRI, ICD, Sudden death
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early cardiac MRI post-STEMI
Arm Type
Experimental
Arm Description
Early stages post-STEMI (within the first 5 days)
Intervention Type
Other
Intervention Name(s)
Gadolinium-enhanced cardiac MRI
Intervention Description
Gadolinium-enhanced cardiac MRI during the 1st days post-STEMI with specific sequences including extra-cellular volume measurement
Primary Outcome Measure Information:
Title
Mesure of zones of delayed myocardial transmural enhancement and no-reflow
Description
Defining the area at risk with Cardiac MRI
Time Frame
40 days
Title
Mesure of ejection fraction and regional wall motion and thickening
Description
Defining the area at risk with Cardiac MRI
Time Frame
40 days
Title
Mesure of extracellular volume
Description
Defining the area at risk with Cardiac MRI
Time Frame
40 days
Secondary Outcome Measure Information:
Title
Number of CVD events
Description
Occurrence of major adverse cardiac events
Time Frame
40 days
Title
Number of admission to the hospital for heart failure event
Description
Occurrence of heart failure events
Time Frame
40 days
Title
Number of ischemic cardiovascular events
Description
Occurrence of major adverse cardiac events
Time Frame
40 days
Title
Number of cardiac death
Description
Occurrence of major adverse cardiac events
Time Frame
40 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
24066194
Citation
Daly C, Kwong RY. Cardiac MRI for myocardial ischemia. Methodist Debakey Cardiovasc J. 2013 Jul-Sep;9(3):123-31. doi: 10.14797/mdcj-9-3-123.
Results Reference
background
PubMed Identifier
21112897
Citation
Perazzolo Marra M, Lima JA, Iliceto S. MRI in acute myocardial infarction. Eur Heart J. 2011 Feb;32(3):284-93. doi: 10.1093/eurheartj/ehq409. Epub 2010 Nov 25.
Results Reference
background
PubMed Identifier
25146709
Citation
Schelbert EB, Wong TC. Imaging the area at risk in myocardial infarction with cardiovascular magnetic resonance. J Am Heart Assoc. 2014 Aug 21;3(4):e001253. doi: 10.1161/JAHA.114.001253. No abstract available.
Results Reference
background
PubMed Identifier
27899132
Citation
Haaf P, Garg P, Messroghli DR, Broadbent DA, Greenwood JP, Plein S. Cardiac T1 Mapping and Extracellular Volume (ECV) in clinical practice: a comprehensive review. J Cardiovasc Magn Reson. 2016 Nov 30;18(1):89. doi: 10.1186/s12968-016-0308-4.
Results Reference
background
PubMed Identifier
28886621
Citation
Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
Results Reference
background
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Use of Cardiac MRI in Early Stages of STEMI to Predict Left Ventricular Function Recovery and ICD Implantation
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