Ischemic Heart DiseaseNCT04970017
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
An observational study of Ischemic Heart Disease, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Cardiac MRI, Echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- • 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut, 71511
Mohamed Abdellatif, 00201001073747, Mohamed.abdellatief@med.au.edu.eg
About this study
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.
Read the 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- Cardiac MRI, Echocardiography
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI, EchocardiographyRadiation
Magnetic resonance imaging, Echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Scare burden by echocardiography
To test the correlation between the scar burden measured by cardiac MRI and GLS measured by 2D STE
Measured: One year
Secondary outcomes (1)
Value of spickle tracking echocardiography in clinical practice
Predicting the scar burden in ICMP patients by GLS and mechanical dispersion.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jan 2021
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Mohamed Abdellatif, Assiut University
- Investigators
- Mohamed Abdellatif, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970017
- Sponsor's protocol ID
- 17200538
- Status last verified
- Feb 2021
- First submitted
- 16 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04970017
- Acronym / sponsor ID
- 17200538
- Conditions
- Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- • 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
Key exclusion criteria (4 listed)
- Patients with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRI, EchocardiographyMagnetic resonance imaging, Echocardiography | Radiation | – |
Primary outcome
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
1 secondary outcome
Value of spickle tracking echocardiography in clinical practice
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
Related trials for Ischemic Heart Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Abdellatif principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdellatif, MSC (+201001073747, mohamed.abdellatief@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scare burden by echocardiography (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.