- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04970017
Correlation Between Left Ventricular Global Strain Measured by Speckle Tracking Echocardiography and Scar Burden Measured by Cardiac Magnetic Resonance Imaging in Patients With Ischemic Heart Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Evaluation of presence, localization, and extent of left ventricular(LV) scar tissue in patients with ischaemic heart disease (IHD) is of fundamental importance in clinical practice. It affects the decision making regarding revascularization and is a determinant of subsequent mortality. (Mele, Fiorencis et al. 2016) Late gadolinium contrast-enhanced cardiac magnetic resonance (LGE-CMR) is considered the current gold standard technique for assessment of the scar burden in IHD patients. However, it is not readily accessible in many areas due to availability and cost issues.(Abou, Prihadi et al. 2020), (Bendary, Afifi et al. 2019) Several recent studies suggested 2-D speckle tracking strain as a potential surrogate for cardiovascular magnetic resonance (CMR) late gadolinium enhancement (LGE) imaging. This would be useful in cases where CMR is not available, gadolinium contrast is contraindicated, or in patients at greater risk of adverse long term events. (Erley, Genovese et al. 2019) Among echocardiography derived strain measurements, global longitudinal strain (GLS) was shown to be superior to global circumferential strain (GCS) in its ability to detect subtle myocardial abnormalities due to better reproducibility (Erley et al, 2019). Left ventricular mechanical dispersion (LVMD) is also considered a valuable parameter that was associated with outcomes after myocardial infarction. (Abou, Prihadi et al. 2020).
Despite the growing number of strain related studies in the literature, it is not clear whether the relationship of strain measurements with LGE is strong enough for strain to be considered as a surrogate. (Erley, Genovese et al. 2019). Also, the differences between GLS and LV MD among strain components in this context are not well established.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mohamed Abdellatif, MSC
- Phone Number: +201001073747
- Email: mohamed.abdellatief@med.au.edu.eg
Study Contact Backup
- Name: Shimaa Sayed Khidr, PHD
- Phone Number: +201001346551
- Email: S.khidr@aun.edu.eg
Study Locations
-
-
-
Assiut, Egypt, 71511
- Recruiting
- Assiut University
-
Contact:
- Mohamed Abdellatif
- Phone Number: 00201001073747
- Email: Mohamed.abdellatief@med.au.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- • Patients presenting for viability assessment in to cardiac MRI unit, Assiut university heart hospital, with a history of previous stemi, at least 3 months after the acute event ( scar stabilization) and up to one year
Exclusion Criteria:
Patients with:
- Contraindication to cardiac MRI (claustrophobia, Patients with eGFR below 30 mL/min/1.73 m2. and patients with metallic implants)
- Non-ischemic cardiomyopathy.
- Valvular heart disease (VHD).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scare burden by echocardiography
Time Frame: One year
|
To test the correlation between the scar burden measured by cardiac MRI and GLS measured by 2D STE
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Value of spickle tracking echocardiography in clinical practice
Time Frame: One year
|
Predicting the scar burden in ICMP patients by GLS and mechanical dispersion.
|
One year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Abdellatif, Assiut University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17200538
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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