Study Stopped
Recruitment difficulties
Use of Cardiac MRI in Early Stages of STEMI to Predict Left Ventricular Function Recovery and ICD Implantation
STEMI-MR
Primary Prevention ICD Implantation in STEMI With Severe Left Ventricular Dysfunction : Input of Early Cardiac MRI in Order to Predict Left Ventricular Recovery
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2018
CompletedFirst Posted
Study publicly available on registry
November 16, 2018
CompletedStudy Start
First participant enrolled
January 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2021
CompletedSeptember 30, 2025
February 1, 2022
2.1 years
November 9, 2018
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mesure of zones of delayed myocardial transmural enhancement and no-reflow
Defining the area at risk with Cardiac MRI
40 days
Mesure of ejection fraction and regional wall motion and thickening
Defining the area at risk with Cardiac MRI
40 days
Mesure of extracellular volume
Defining the area at risk with Cardiac MRI
40 days
Secondary Outcomes (4)
Number of CVD events
40 days
Number of admission to the hospital for heart failure event
40 days
Number of ischemic cardiovascular events
40 days
Number of cardiac death
40 days
Study Arms (1)
Early cardiac MRI post-STEMI
EXPERIMENTALEarly stages post-STEMI (within the first 5 days)
Interventions
Gadolinium-enhanced cardiac MRI during the 1st days post-STEMI with specific sequences including extra-cellular volume measurement
Eligibility Criteria
You may qualify if:
- Acute STEMI within 5 last days with LVEF \< 35%
- years old
- Admitted to the Cardiac ICU
- Consent form
You may not qualify if:
- CABG surgery indicated
- Contra-indications to MRI
- ICD or PPM in place
- Follow-up compromised
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Montpellierlead
- Société Française de Cardiologiecollaborator
Study Sites (1)
University Hospital of Montpellier
Montpellier, 34090, France
Related Publications (5)
Tangerman A. Determination of volatile sulphur compounds in air at the parts per trillion level by Tenax trapping and gas chromatography. J Chromatogr. 1986 Sep 24;366:205-16. doi: 10.1016/s0021-9673(01)93468-5.
PMID: 3782318BACKGROUNDPerazzolo 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.
PMID: 21112897BACKGROUNDSchelbert 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.
PMID: 25146709BACKGROUNDHaaf 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.
PMID: 27899132BACKGROUNDIbanez 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.
PMID: 28886621BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2018
First Posted
November 16, 2018
Study Start
January 7, 2019
Primary Completion
February 22, 2021
Study Completion
February 22, 2021
Last Updated
September 30, 2025
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share