Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
NCT ID: NCT02917213
Last Updated: 2022-02-04
Study Results
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Basic Information
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COMPLETED
92 participants
OBSERVATIONAL
2016-09-30
2022-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Doppler echocardiogram exam
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.
Carotid duplex ultrasound exam
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.
Cardiac MRI
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.
Brain MRI
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.
Reveal LINQ insertable cardiac monitoring system
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.
Coagulation blood test
5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment, at one week and 6 months after enrollment.
Transcranial Doppler monitoring
A Transcranial Doppler monitoring will be performed in the first 24 hours after enrollment in order to detect High Intensity Transient Signals (HITs).
Interventions
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Doppler echocardiogram exam
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.
Carotid duplex ultrasound exam
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.
Cardiac MRI
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.
Brain MRI
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.
Reveal LINQ insertable cardiac monitoring system
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.
Coagulation blood test
5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment, at one week and 6 months after enrollment.
Transcranial Doppler monitoring
A Transcranial Doppler monitoring will be performed in the first 24 hours after enrollment in order to detect High Intensity Transient Signals (HITs).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Hospital General Universitario Gregorio Marañon
OTHER
Responsible Party
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Javier Bermejo Thomas
Non-invasive Cardiology Section Chief, Department of Cardiology
Principal Investigators
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Javier Bermejo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañón
Locations
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Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Countries
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References
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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.
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.
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.
Other Identifiers
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FIBHGM-ISBITAMI
Identifier Type: -
Identifier Source: org_study_id
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