Ischemic CardiomyopathyNCT04588675
Stress Cardiac MRI in Ischemic Patients
An observational study of Ischemic Cardiomyopathy, run by Assiut University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- MRI
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Jun 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 patients with chronic LV systolic dysfunction due to coronary artery disease (CAD)
Who may be able to join
- All patients recruited into the study have chronic LV systolic dysfunction due to coronary artery disease (CAD)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
- Conditions
- Ischemic Cardiomyopathy
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
the patients will underwent dobutamine stress cardiac MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of myocardial strain with late gadolinium enhancement
analysis of the myocardial strain by low dose dobutamine and test if it can assess myocardial viability
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study startNov 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic CardiomyopathyStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Emam Eldeen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588675
- Sponsor's protocol ID
- Stress cardiac MRI
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31868950Schuster 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.
PubMed 22130224
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Myocardial Viability by Cardiac Magnetic Resonance Feature Tracking at Rest and During Stress by Low Dose Dobutamine
- ClinicalTrials.gov ID
- NCT04588675
- Acronym / sponsor ID
- Stress cardiac MRI
- Conditions
- Ischemic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 19 Oct 2020 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with chronic LV systolic dysfunction due to coronary artery disease (CAD)
Key inclusion criteria (1 listed)
- All patients recruited into the study have chronic LV systolic dysfunction due to coronary artery disease (CAD)
Key exclusion criteria (6 listed)
- All patients with a contraindication to MR study:
- 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
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 |
|---|---|---|
| MRIthe patients will underwent dobutamine stress cardiac MRI | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 31868950Bhutani 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.
- Background: PubMed 22130224Schuster 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.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Cardiomyopathy, run by Assiut University.
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 6 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Abdulrahman Hamdan (1005363950 ext. 0020, abdulrahman.emam@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of myocardial strain with late gadolinium enhancement (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04588675, which also lists 2 linked publications.
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 19 Oct 2020.