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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04970017
Other study ID # 17200538
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 2022

Study information

Verified date February 2021
Source Assiut University
Contact Mohamed Abdellatif, MSC
Phone +201001073747
Email mohamed.abdellatief@med.au.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To verify whether GLS and LV mechanical dispersion, measured by two-dimensional speckle-tracking echocardiography (2D-STE) correlate with LV scar burden measured by cardiac MRI in patients with ischemic heart disease.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 51
Est. completion date January 2022
Est. primary completion date January 2022
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Radiation:
Cardiac MRI, Echocardiography
Magnetic resonance imaging, Echocardiography

Locations

Country Name City State
Egypt Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scare burden by echocardiography To test the correlation between the scar burden measured by cardiac MRI and GLS measured by 2D STE One year
Secondary Value of spickle tracking echocardiography in clinical practice Predicting the scar burden in ICMP patients by GLS and mechanical dispersion. One year
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