Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction

NCT02917213 | Completed

• 1 other identifier: FIBHGM-ISBITAMI
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

acute myocardial infarction; cardiac embolism; intracardiac fluid dynamics; silent brain infarct; intracardiac blood stasis

Outcome Measures

Primary Outcomes (1)

• 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

  Individual outcome measurements as described in Secondary Outcome Measures Section

  6 months

Secondary Outcomes (6)

• Left ventricle mural thrombosis assessed by cardiac MRI performed one week and 6 months after STEMI

  6 months

• Silent brain infarcts (SBI) within the 6 months following a first STEMI

  6 months

• Peripheral acute arterial embolism (limb or visceral) within the 6 months following a first STEMI

  6 months

• Ischemic stroke within the 6 months after STEMI

  6 months

• 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

Study Arms (1)

StudyGroup

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.

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

Interventions

Doppler echocardiogram exam OTHER

A complete echocardiographic study will be performed in the first 24 hours, and after a week and 6 months after enrollment. The echocardiographic images will be acquired as clinically recommended. The protocol will include the acquisition of 1) 2D images in parasternal axis long and short axis; 2) 2D and Doppler tissue images in the apical planes of 4, 2 and 3 chambers; 3) Pulsed, continuous and color Doppler M (DCMM) of transmitral LV flow and LV ejection; 4) 3-Chamber apical plane with and without color Doppler; and 5) 3D LV images. DCMM images will be obtained from the apical window using 4 and 5 chamber planes. Blood flow velocity will be obtained using Color and Gray mode in the 3 chamber view during 5-10 beats in apnea.

StudyGroup

Carotid duplex ultrasound exam OTHER

A B-mode and Doppler ultrasound study will be performed using a linear probe 9L (9 MHz) for the evaluation of the common carotid artery bulb, the carotid bifurcation and the internal carotid during 24 h after enrollment. Intima-media thickness will be measured. Turbulent flow velocities in the area of stenosis will be measured by Doppler. The criteria used to grade the severity of carotid atherosclerotic disease will follow the Consensus Conference of the Society of Radiologist in Ultrasound 2003.

StudyGroup

Cardiac MRI OTHER

A cardiac MR will be acquired a week and 6 months after enrollment. The protocol includes the following sequences: cine mode of short axes from LV base to apex, 2-3-4 chambers and STIR +T2 sequence. Perfusion during the administration of a bolus of 0.05 mmol / kg Gadovist®. 3D sequence of late enhancement of inversion-recovery. Images will be acquired after 10 min of the administration of a total of 0.2 mmol / g of Gadovist®. Intraventricular thrombosis will be monitored. Phase contrast sequences in three orthogonal planes will be acquired. Morphological parameters of LV function (LVEF), contractility ("Wall Motion Score "), sphericity index, infarct size, area at risk, edema, microvascular obstruction and first-pass perfusion will be obtained.

StudyGroup

Brain MRI OTHER

A brain MR will be acquired a week and 6 months after enrollment. Axial, sagittal and coronal spin echo sequence in T1, axial images in diffusion sequences (DWI), enhanced spin echo T2 and FLAIR (fluid-attenuated inversion recovery) sequences shall be obtained. A cerebral infarction will be positive when finding the presence of a focal lesion of\> 3 mm in diameter that meets one of these three characteristics: (1) high signal on isotropic DWI images and low signal on the apparent coefficient map Broadcast (ADC). (2) Cavitary lesion hyperintense on T2, with no signal (or low) in the FLAIR sequence. (3) Hyperintense lesion T2 / T1 hypointense with prior distribution defect known or new in a follow-up study.

StudyGroup

Reveal LINQ insertable cardiac monitoring system PROCEDURE

A Reveal LINQ insertable cardiac monitoring system will be implanted following 1:1 patient unblinded randomization (device:no device). The device will be interrogated at a week after implantation and at 6 months, or if symptoms (palpitations or syncope) have activated the device memory.

StudyGroup

Coagulation blood test OTHER

5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment, at one week and 6 months after enrollment.

StudyGroup

Transcranial Doppler monitoring OTHER

A Transcranial Doppler monitoring will be performed in the first 24 hours after enrollment in order to detect High Intensity Transient Signals (HITs).

StudyGroup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (1)

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Related Publications (3)

• 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.

  PMID: 26680013 BACKGROUND

• 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.

  PMID: 17582361 BACKGROUND

• Rodriguez-Gonzalez E, Martinez-Legazpi P, Mombiela T, Gonzalez-Mansilla A, Delgado-Montero A, Guzman-De-Villoria JA, Diaz-Otero F, Prieto-Arevalo R, Juarez M, Garcia Del Rey MDC, Fernandez-Garcia P, Flores O, Postigo A, Yotti R, Garcia-Villalba M, Fernandez-Aviles F, Del Alamo JC, Bermejo J. Stasis imaging predicts the risk of cardioembolic events related to acute myocardial infarction: the ISBITAMI study. Rev Esp Cardiol (Engl Ed). 2025 Jan;78(1):22-33. doi: 10.1016/j.rec.2024.04.007. Epub 2024 May 8.

  PMID: 38729343 DERIVED

MeSH Terms

Conditions

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

Interventions

Blood Coagulation Tests

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Disease Attributes; Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Javier Bermejo, MD, PhD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Non-invasive Cardiology Section Chief, Department of Cardiology

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 28, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: February 4, 2022

Record last verified: 2022-02

Locations

ES (1)