Coronary Revascularization Based on CMR Viability Study Vs Direct Revascularization in Ischemic Cardiomyopathy Patients

January 14, 2022 updated by: Ahmed Attiya Abdelmuty Mahmoud, Assiut University

Comparison Between Coronary Revascularization Based on CMR Viability Study Vs Direct Revascularization in Patients With Ischemic Cardiomyopathy

The study aiming to demonstrate the baseline characteristics and outcomes of patients undergoing revascularization by PCI vs those kept only on medical treatment, based on CMR viability assessment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiac magnetic resonance (CMR) has an ever-increasing role in the assessment and management of patients with coronary artery disease (CAD). Advantages of CMR include the lack of ionizing radiation and its flexibility, high spatial resolution, and three-dimensional capabilities that enable imaging in any desired plane.

In the evaluation of patients with ischemic cardiomyopathy, CMR is primarily used in the setting of chronic CAD for the evaluation of myocardial ischemia and viability.

Left ventricular systolic dysfunction, resulting from coronary artery disease is reversible with revascularization in cases of hibernation and stunned myocardium. Revascularization is dependent not only on the presence but also the extent of viability, and a viable myocardium is necessary for functional recovery.

In a CMR study, in areas with dysfunctional myocardium as detected in cine sequences, the end diastolic wall thinning >5.5 mm, the extent of subendocardial fibrosis together with response to low dose dobutamine were shown to predict functional recovery.

However, in the famous viability sub study of the STICH (Surgical Treatment for Ischemic Heart Failure) trial, there was a significant association between myocardial viability and outcome by univariate analysis, but not on multivariable analysis. Thereby, the value of CMR in this regards is still debatable.

So, according to the recent state of art paper from the American Heart Association, data is still limited regarding CMR use to guide revascularization strategies or predict outcomes in patients with severe LV dysfunction. The statement recommended that future trials should continue to address the clinical impact of specific modality-based strategies or multimodality strategies in guiding treatment in terms of patient outcomes.

On the other hand, appropriately guided coronary revascularization may go beyond providing recovery of myocardial systolic contractility by improving patient's functional class and heart failure symptoms, enhancing diastolic relaxation, reducing the burden of rhythm abnormalities, or decreasing the burden of polypharmacy, thereby reducing the risk of drug toxicity and improving quality of life. These additional benefits need also to be explored in clinical trials.

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ischemic cardiomyopathy patients

Description

Inclusion Criteria:

  1. Patients >18 years of age, with LVEF<40%.
  2. Patients presenting for viability assessment to Assiut university Heart Hospital, starting from October 2020 till September 2021, will be retrospectively recruited.
  3. Patients with a coronary angiography that is amenable for revascularization. The decision and type of revascularization will be determined by the treating physicians.

Exclusion Criteria:

  1. Classic CMR and gadolinium-based dye contraindications including non-MRI compatible implants/foreign bodies (e.g. non-MRI compatible pacemaker, large pieces of shrapnel) and patients with eGFR<30 ml/min/1.73 m2.
  2. Patients with non-ischemic cardiomyopathy confirmed by both CMR and coronary angiography.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CMR viability study group

Diagnostic Test: CMR Basic CMR data including LV and RV volumes, SWMA reported, EF and wall thinning will be collected.

  • SWMA from SSFP sequences will be reported and numbered according to the usual (1 normal, 2 hypokinetic, 3 akinetic, 4 dyskinetic, 5 aneurysmal).
  • Data of viability assessed with LGE imaging with scar measurement using standard deviation method with SD of 4-5 will be used.
  • AHA 17 segment model will be used as a reference for LV segmentation.
  • Viability scoring will be calculated for each segment based on the transmurality index, in a semiautomated method, with no scar given 0, 1-25% subendocardial scar given score 1, 25-50% given 2, 50-75% given 3, >75% as 4.
  • Wall thinning will be given 0 or 1 score for each segment, with 1 given for <6 mm thickness.
Device: cardiac MRI
assessment of the viability using CMR
Other Names:
  • CMR
direct revascularization group
Direct Coronary revascularization
Procedure: Percutaneous coronary intervention
direct revascularization using PCI
Other Names:
  • PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of death, myocardial infarction , arrhythmia and hospitalization for HF
Time Frame: 6-12 months after revascularization or medical treatment based on CMR viability testing.
Detection of death, myocardial infarction (not related to index procedure) and hospitalization for heart failure or arrhythmia at 6-12 months after revascularization or medical treatment based on CMR viability testing.
6-12 months after revascularization or medical treatment based on CMR viability testing.

Secondary Outcome Measures

Outcome Measure
Time Frame
- Quality of life assessment using Kansas Qol questionnaire.
Time Frame: 6-12 months after revascularization or medical treatment based on CMR viability testing.
6-12 months after revascularization or medical treatment based on CMR viability testing.
- Improvement of echocardiography measured LVEF at 6-12 months after revascularization.
Time Frame: 6-12 months after revascularization or medical treatment based on CMR viability testing.
6-12 months after revascularization or medical treatment based on CMR viability testing.
- Detection of the effect of delayed revascularization after the CMR viability study on the outcome.
Time Frame: 6-12 months after revascularization or medical treatment based on CMR viability testing.
6-12 months after revascularization or medical treatment based on CMR viability testing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Hosam H. Elaraby, PhD, Professor at cardiovascular medicine department , assiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMR Vs PCI revascularization

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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