Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction

Completed

• Conditions: Stroke; Acute Disease; Thrombosis; Heart Diseases; Myocardial Infarction
• Interventions: Other: Doppler echocardiogram exam; Other: Carotid duplex ultrasound exam; Other: Cardiac MRI; Other: Brain MRI; Procedure: Reveal LINQ insertable cardiac monitoring system; Other: Coagulation blood test; Other: Transcranial Doppler monitoring

• Registration Number: NCT02917213
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-28
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
StudyGroup	Carotid duplex ultrasound exam	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.
StudyGroup	Doppler echocardiogram exam	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.
StudyGroup	Transcranial Doppler monitoring	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.
StudyGroup	Cardiac MRI	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.
StudyGroup	Brain MRI	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.
StudyGroup	Reveal LINQ insertable cardiac monitoring system	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.
StudyGroup	Coagulation blood test	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.

Primary Outcome Measures

Name	Time	Method
Combined binary variable consisting of one of the following: ventricular thrombosis assessed by cardiac MRI, silent brain infarct detected by brain MRI, peripheral acute arterial embolism or ischemic stroke within the 6 months after a first STEMI	6 months	Individual outcome measurements as described in Secondary Outcome Measures Section

Secondary Outcome Measures

Name	Time	Method
Silent brain infarcts (SBI) within the 6 months following a first STEMI	6 months	SBIs diagnosis entails the presence of a focal lesion \> 3 mm that meets one of the three following criteria: 1) high signal on DWI isotropic images and low signal on the map of apparent diffusion coefficient (ADC). DWI sequence allows to detecting ischemic lesions (4 hours) and assessing their chronology. (2) cavitary lesion hyperintense on T2, with no signal (or low) in the FLAIR sequence usually surrounded by a ring gliotic hyperintense, hypointense on T1). (3) hyperintense lesion on T2 / T1 hypointense with prior distribution defect known or new in a follow-up study. The studies will be interpreted by a neuroradiologist blinded to clinical and echocardiographic information. For the assessment of whether the brain infarct is clinically silent, a medical history and physical examination focused on neurological symptoms will be performed including for that purpose the National Institute of Health (USA) questionnaire
Ischemic stroke within the 6 months after STEMI	6 months	An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction within the 6 months following a first STEMI, confirmed by clinically-indicated imaging technique (CT or MRI).
Left ventricle mural thrombosis assessed by cardiac MRI performed one week and 6 months after STEMI	6 months	Left ventricle mural thrombosis will be assessed by contrast cardiac MRI. Early after gadolinium contrast administration (3 min), two dimensional T1-weighted fast-field-echo sequences with an inversion-recovery prepulse will be used. A long inversion time (520 ms) will be used to identify intraventricular thrombus as a LV mass with low-signal intensity surrounded by high-signal intensity structures
Peripheral acute arterial embolism (limb or visceral) within the 6 months following a first STEMI	6 months	Incidence of acute limb ischemia (characterized by pain, pallor, pulselessness, poikilothermia, paresthesias, paralysis) and/or acute visceral ischemia (renal or mesentheric acute isquemia) within the 6 months following a first STEMI, as confirmed by clinically-indicated imaging technique.
High Intensity Transient Signals (HITs) detected by transcranial Doppler monitoring of both middle cerebral arteries during 30 minutes within the 24-72 hours after STEMI	24-72 hours
Neuropsychiatric and cognitive impact of SBIs within the 6 months after STEMI assessed by Beck and Minimental questionnaire	6 months

Trial Locations

Locations (1)

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain