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

Acute STEMI Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03743935
• Other study ID #: UF 7649
• Status: Terminated
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: February 22, 2021

Study information

• Verified date: February 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute STEMI
• Severe Left Ventricular Systolic Dysfunction (Disorder)
• ST Elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Montpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Société Française de Cardiologie

Country where clinical trial is conducted

France, 

References & Publications (5)

Daly C, Kwong RY. Cardiac MRI for myocardial ischemia. Methodist Debakey Cardiovasc J. 2013 Jul-Sep;9(3):123-31. Review. — View 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. Review. — View 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, Widimský 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. — View 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. Review. — View 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). pii: e001253. doi: 10.1161/JAHA.114.001253. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mesure of zones of delayed myocardial transmural enhancement and no-reflow	Defining the area at risk with Cardiac MRI	40 days
Primary	Mesure of ejection fraction and regional wall motion and thickening	Defining the area at risk with Cardiac MRI	40 days
Primary	Mesure of extracellular volume	Defining the area at risk with Cardiac MRI	40 days
Secondary	Number of CVD events	Occurrence of major adverse cardiac events	40 days
Secondary	Number of admission to the hospital for heart failure event	Occurrence of heart failure events	40 days
Secondary	Number of ischemic cardiovascular events	Occurrence of major adverse cardiac events	40 days
Secondary	Number of cardiac death	Occurrence of major adverse cardiac events	40 days