Clinical trial NCT02917213: Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Official title: A Prospective, Observational Study to Assess the Efficacy of New Quantitative Imaging Methods to Assess the Risk of Acute and Subacute Thromboembolic Complications of Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Acute Disease
Thrombosis
Heart Diseases
Stroke
Keywords: acute myocardial infarction
cardiac embolism
intracardiac fluid dynamics
silent brain infarct
intracardiac blood stasis
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of 92 patients with first ST elevation acute myocardial infarction (AMI), LV ejection fraction \< 45% in the first 24-72 h after symptoms onset and sinus rhythm will be enrolled

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Left ventricle mural thrombosis assessed by cardiac MRI performed one week and 6 months after STEMI
timeFrame: 6 months
measure: Silent brain infarcts (SBI) within the 6 months following a first STEMI
timeFrame: 6 months
measure: Peripheral acute arterial embolism (limb or visceral) within the 6 months following a first STEMI
timeFrame: 6 months
measure: Ischemic stroke within the 6 months after STEMI
timeFrame: 6 months
measure: 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
timeFrame: 24-72 hours
measure: Neuropsychiatric and cognitive impact of SBIs within the 6 months after STEMI assessed by Beck and Minimental questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón
name: Javier Bermejo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rossini L, Martinez-Legazpi P, Vu V, Fernandez-Friera L, Perez Del Villar C, Rodriguez-Lopez S, Benito Y, Borja MG, Pastor-Escuredo D, Yotti R, Ledesma-Carbayo MJ, Kahn AM, Ibanez B, Fernandez-Aviles F, May-Newman K, Bermejo J, Del Alamo JC. A clinical method for mapping and quantifying blood stasis in the left ventricle. J Biomech. 2016 Jul 26;49(11):2152-2161. doi: 10.1016/j.jbiomech.2015.11.049. Epub 2015 Nov 30.
citation: Vermeer SE, Longstreth WT Jr, Koudstaal PJ. Silent brain infarcts: a systematic review. Lancet Neurol. 2007 Jul;6(7):611-9. doi: 10.1016/S1474-4422(07)70170-9.