- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04588675
Stress Cardiac MRI in Ischemic Patients
October 9, 2020 updated by: Abdulrahman Emam Eldeen, Assiut University
Assessment of Myocardial Viability by Cardiac Magnetic Resonance Feature Tracking at Rest and During Stress by Low Dose Dobutamine
The aim of this study is to assess the diagnostic accuracy of CMR feature-tracking (FT) at rest & during stress with low dose dobutamine (LDD) in the evaluation of viability in ischemic cardiomyopathy (ICM) patients and compare it with delayed gadolinium enhancement (DGE).
Study Overview
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
50 patients with chronic LV systolic dysfunction due to coronary artery disease (CAD)
Description
Inclusion Criteria:
- All patients recruited into the study have chronic LV systolic dysfunction due to coronary artery disease (CAD)
Exclusion Criteria:
All patients with a contraindication to MR study:
- Patients with implanted non-MRI compatible electronic devices (e.g. Cardiac pacemakers, intracranial metallic clips, implanted hearing aids, etc.)
- Patients with foreign bodies in the eye.
- Claustrophobic patients.
- Patients diagnosed with recent acute coronary syndrome within 4 weeks.
- Patients who had contraindications for MRI or contrast agents, and those with poor image quality due to either inadequate breath holding or arrhythmias
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comparison of myocardial strain with late gadolinium enhancement
Time Frame: Baseline
|
analysis of the myocardial strain by low dose dobutamine and test if it can assess myocardial viability
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Bhutani M, Vatsa D, Rahatekar P, Verma D, Nath RK, Pandit N. Role of strain imaging for assessment of myocardial viability in symptomatic myocardial infarction with single vessel disease: An observational study. Echocardiography. 2020 Jan;37(1):55-61. doi: 10.1111/echo.14567. Epub 2019 Dec 23.
- Schuster A, Paul M, Bettencourt N, Morton G, Chiribiri A, Ishida M, Hussain S, Jogiya R, Kutty S, Bigalke B, Perera D, Nagel E. Cardiovascular magnetic resonance myocardial feature tracking for quantitative viability assessment in ischemic cardiomyopathy. Int J Cardiol. 2013 Jun 20;166(2):413-20. doi: 10.1016/j.ijcard.2011.10.137. Epub 2011 Nov 29.
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)
November 1, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
October 9, 2020
First Submitted That Met QC Criteria
October 9, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
October 19, 2020
Last Update Submitted That Met QC Criteria
October 9, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Stress cardiac MRI
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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