Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction (ISBITAMI)

Hospital General Universitario Gregorio Marañon

Status: Completed

Conditions: Stroke; Thrombosis; Acute Disease; Myocardial Infarction; Heart Diseases

Treatments: Other: Doppler echocardiogram exam; Other: Transcranial Doppler monitoring; Other: Coagulation blood test; Other: Cardiac MRI; Other: Brain MRI; Procedure: Reveal LINQ insertable cardiac monitoring system; Other: Carotid duplex ultrasound exam

Study type: Observational

Funder types: Other

Identifiers

NCT02917213

FIBHGM-ISBITAMI

Details and patient eligibility

About

This project aims to assess the ability of cardiac imaging (cardiac MRI and Doppler-echocardiography) post-processing tools to predict a combined end-point of intraventricular thrombosis, silent brain infarcts, clinical stroke and peripheral arterial embolism in patients with first acute myocardial infarction and ventricular dysfunction.

Full description

An acute myocardial infarction (AMI) is a clinical situation that entails an increased risk of both subclinical and clinically devastating cardioembolic events. This increased risk of embolic phenomena may be related to blood stasis caused by alterations in the blood flow inside the left ventricle (LV) after AMI. Using flow velocity measurements obtained by cardiac MRI and Doppler-echocardiography it is possible to quantify the stasis in the LV and assess its relation to the risk of embolic events. The ability of cardiac imaging (cardiac MRI and Doppler-echocardiography) post-processing tools to predict embolic events in a cohort of 92 patients with a first AMI and left ventricular dysfunction shall be addressed. The potential confusion generated by the possible existence of paroxysmal AF will be controlled by implanting cardiac monitoring devices in random order in a subset of patients.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. First ST elevation AMI undergoing (or not) revascularization.
2. Sinus rhythm in the first 24 hours of the AMI.
3. Written informed consent. ( 4) Left ventricular ejection fraction < 45% measured by echocardiography in the first 24-72 hours after AMI symptoms onset.

Exclusion criteria

1. Implantable defibrillation or stimulation devices not compatible with MRI.
2. Killip-IV class or other shock situations or marked peripheral hypoperfusion.
3. Aborted sudden death or other causes of possible acute brain damage attributed to cerebral hypoperfusion.
4. Hemodynamically significant valvular disease or prosthetic heart valves.
5. Claustrophobia that impedes MRI scanning.
6. Atrial fibrillation (AF) in the first 24 hours after AMI.
7. Carotid Artery Disease diagnosed with stenosis greater than 50%.
8. Full oral anticoagulation prior to admission or indication of anticoagulation.
9. Defined pro-thrombotic conditions.
10. History of previous stroke in the last 6 months.

Trial design

92 participants in 1 patient group

StudyGroup

Description:

A cohort of 92 patients with first ST elevation acute myocardial infarction (AMI), sinus rhythm, and LV ejection fraction \< 45% in the first 24-72 h after symptoms onset. In the first 24 hours after enrollment a coagulation blood test, a Doppler echocardiogram exam, a Carotid duplex ultrasound exam, a Transcranial Doppler monitoring and a Reveal LINQ insertable cardiac monitoring system will be 1:1 randomly implanted. A clinical examination (including neuropsiquiatric evaluation), a Doppler echocardiogram exam, a cardiac MRI and a brain MRI will be performed after a week and after 6 months after enrollment.

Treatment:

Other: Coagulation blood test

Other: Cardiac MRI

Other: Doppler echocardiogram exam

Procedure: Reveal LINQ insertable cardiac monitoring system

Other: Carotid duplex ultrasound exam

Other: Transcranial Doppler monitoring

Other: Brain MRI