The Assessment Of Myocardial Viability Based On CTA/MRI Hybrid Models

NCT04397198 | Completed

• 1 other identifier: CM0120-HYBH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of HYBRIDHEART study is to develop new imagistic prototype for a complex evaluation of the myocardial viability by superposing computed tomographic angiographic polar maps of the myocardium with magnetic resonance imaging contractile maps in subjects who suffered an acute myocardial infarction. Moreover, the study will evaluate the association of myocardial viability with the level of inflammatory markers and the percent of myocardial fibrosis, also will correlate the imaging-derived parameters with the inflammatory status of the patients, left ventricular function, ischemic time and major adverse cardiovascular events (MACE) rate.

Conditions

Acute Myocardial Infarction; Myocardial Viability; Vulnerable Coronary Plaques; Coronary Stenosis; Myocardial Fibrosis

Keywords

biomarkers; myocardial infarction; hybrid images; myocardial viability; CCTA; MRI

Outcome Measures

Primary Outcomes (1)

• Hybrid imaging

  the development of the new hybrid imaging features: plaque vulnerability degree, % of myocardial scar, % of viable myocardial tissue

  6 months

Secondary Outcomes (1)

• Correlations

  12 months

Study Arms (1)

HIBRIDH-SG 01

Study subjects with documented ST segment Elevation Myocardial Infarction

Diagnostic Test: Speckle Tracking echocardiography

Interventions

Speckle Tracking echocardiography DIAGNOSTIC_TEST

Diagnostic tests: Speckle Tracking echocardiography with analyzing the myocardial strain, myocardial velocities, 128-multislice CCTA with the evaluation of the Calcium Scoring (total and local) , identifying the coronary stenosis, evaluation of the plaque vulnerability degree, assess polar maps of the myocardium. MRI for the evaluation of the percentage of myocardial scar, also the percentage of the viable myocardial tissue using contrast late enhancement sequences, measuring myocardial fibrosis using Q-mass software. Diagnostic tests: Laboratory assessment for the evaluation of the level of hs-CRP and myocardial necrosis biomarkers

Also known as: 128-multislice CCTA, MRI, Laboratory assessment

HIBRIDH-SG 01

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 subjects with documented ST Segment elevation myocardial infarction at 30 days prior to study enrollment.

You may qualify if:

• Patients aged more than 18 years old
• Patients with documented ST segment Elevation Myocardial Infarction in the last 30 days
• Patients who signed the written consent.

You may not qualify if:

• Subjects with renal impairment, or contrast intolerance
• Pregnant women
• Patients known with malignancy in the last year
• Non-compliant patients
• Patients older than 90 years

Sponsors & Collaborators

• Cardio Med Medical Center: lead
• University of Targu Mures, Romania: collaborator
• Tîrgu Mureș Emergency Clinical County Hospital, Romania: collaborator

Study Sites (1)

Cardio Med

Târgu Mureş, Mureș County, Romania

Location

Biospecimen

Retention: SAMPLES WITH DNA

venous blood samples for evaluation of the level of hs-CRP, myocardial necrosis markers

MeSH Terms

Conditions

Coronary Stenosis; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2020
• First Posted: May 21, 2020
• Study Start: July 6, 2020
• Primary Completion: July 6, 2021
• Study Completion: June 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The IPD sharing time is starting 6 months after the publication.

Locations

RO (1)