Coronary Artery DiseaseCMRNCT04247698
Hemodynamic Forces at Rest and Stress vs. Adenosine and Dobutamine Stress Cardiac Magnetic Resonance
An observational study of Coronary Artery Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Stress perfusion CMR has recently considered as one of the methods of choice for establishing the diagnosis of CAD based on its high diagnostic accuracy, lack of ionizing radiation as well as its ability to simultaneously assess the cardiac function, myocardial perfusion, and viability, however, there are some… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2020to 31 Mar 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population are known to have coronary artery disease and underwent revascularization therapy via bypass surgery around 10 years before the initial CMR examination. Those presented with manifestations of recurrent post-CABG angina, with either typical or atypical presentation. Each patient had two CMR examinations on two occasions using both dobutamine and adenosine stress agents.
Who may be able to join
- Patients with established CAD and underwent coronary artery bypass graft surgery (CABG) performed around 10 years before the initial CMR examination. Who presented to CMR examination because of recurrent typical/ atypical angina.
Who cannot join
- All patients that were not able to withstand the condition of CMR examination
- Patients who had contraindications to the stressor agents used in stress CMR were not included in the analysis (i.e. bronchial asthma, high degree heart-block)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71516
Ayat Abdelgalil, Msc., +2 01144478313, soze2080@gmail.com
Hatem Helmy, MD, +2 01005212162, hatem19652007@yahoo.com
About this study
Official title: Prognostic Value of Hemodynamic Forces at Rest and Stress Compared to Adenosine and Dobutamine Stress Cardiac Magnetic Resonance
Stress perfusion CMR has recently considered as one of the methods of choice for establishing the diagnosis of CAD based on its high diagnostic accuracy, lack of ionizing radiation as well as its ability to simultaneously assess the cardiac function, myocardial perfusion, and viability, however, there are some concerns on its suitability for assessment of myocardial perfusion in patients after coronary artery bypass graft surgery who suffer from recurrent angina. The study of hemodynamic forces offers a promising tool for further understanding of the interplay between the myocardium and blood as well as the mechanisms of cardiac filling. This work represents a retrospective follow up study of CMR data, available on CMR-database, from 112 patients with previous coronary artery bypass grafting (CABG) performed around 10 years before the initial CMR examination. The study subjects underwent stress CMR testing; using both stressors; dobutamine and adenosine (done on two separate occasions). Injection of gadolinium contrast medium for late gadolinium enhancement was done with adenosine stress testing for late gadolinium enhancement (LGE). Offline analysis of these data will be done with the use of dedicated software for assessment for myocardial ischemia together with quantitative measurements of the hemodynamic forces with the help of dedicated software (QStrain version 1.3.0.79; Medis, Leiden, the Netherlands).
Read the detailed description
In total 112 patients who underwent coronary artery bypass surgery (CABG) subjected to stress CMR examination on two separate occasions with both stressors; dobutamine and adenosine for assessment of myocardial ischemia as result of typical /atypical angina pectoris. The results from dobutamine (namely, detection of wall motion abnormalities) and adenosine stress CMR (namely, detection of perfusion abnormalities) will be compared with the values obtained from the measures of the hemodynamic forces of the LV (i.e., changes in the intraventricular pressures during systole and diastole). The dimensionless root mean square (FRMS) is computed over the entire heartbeat as a measure of the overall force amplitude. In addition, LV global longitudinal strain (GLS) and LV global circumferential strain (GCS) will be measured using a CMR feature tracking techniques. The expected results are as follows: Dobutamine wall motion analysis in combination with perfusion imaging has the highest diagnostic accuracy for the detection of ischemia in patients after bypass surgery and outperforms pure dobutamine wall motion or perfusion analysis and adenosine perfusion. Whereas, perfusion imaging with both stressors reflects the extent of ischemia more precisely than wall motion analysis. Nevertheless, assessment of hemodynamic forces adds to the diagnostic accuracy as well as the prognostic value of stress CMR in post-CABG patients, in whom stress testing with either or both stressors might fail to precisely define myocardial ischemia or reflect an associated subtle cardiac dysfunction.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of hard and soft cardiac events and their relation to initial positive or negative Stress-CMR-test.
Hard cardiac outcomes are defined defined as deaths that are attributed to coronary artery disease, and non-fatal myocardial infarction. While soft events are defined as angina, or repeat revascularization for progressive coronary artery disease.
Measured: 1 year
Secondary outcomes (2)
Definition of the prognostic value of vasodilator stress and inotropic stress-CMR in patients with chronic CAD and a history of CABG.
The capability of both stressors to detect precisely the presence recurrent ischaemia in patients with CAD on both CMR examinations
Measured: 1 year
Evaluation of the diagnostic accuracy of hemodynamic forces and assessment of the relationship to inducible wall motion abnormalities and perfusion defects.
The power of how much the analysis of hemodynamic forces in comparison to adenosine and dobutamine to precisely detect ischaemic changes in either positive and negative stress CMR in such patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start7 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Aboutaleb Abdellah Abdelgalil, Assiut University
- Investigators
- Amr Youssef, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247698
- Sponsor's protocol ID
- HDF
- Acronym
- CMR
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Hemodynamic Forces at Rest and Stress Compared to Adenosine and Dobutamine Stress Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT04247698
- Acronym / sponsor ID
- CMR / HDF
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 30 Jan 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.
Stress perfusion CMR has recently considered as one of the methods of choice for establishing the diagnosis of CAD based on its high diagnostic accuracy, lack of ionizing radiation as well as its ability to simultaneously assess the cardiac function, myocardial perfusion, and viability, however, there are some concerns on its suitability for assessment of myocardial perfusion in patients after coronary artery bypass graft surgery who suffer from recurrent angina. The study of hemodynamic forces offers a promising tool for further understanding of the interplay between the myocardium and blood as well as the mechanisms of cardiac filling. This work represents a retrospective follow up study of CMR data, available on CMR-database, from 112 patients with previous coronary artery bypass grafting (CABG) performed around 10 years before the initial CMR examination. The study subjects underwent stress CMR testing; using both stressors; dobutamine and adenosine (done on two separate occasions). Injection of gadolinium contrast medium for late gadolinium enhancement was done with adenosine stress testing for late gadolinium enhancement (LGE). Offline analysis of these data will be done with the use of dedicated software for assessment for myocardial ischemia together with quantitative measurements of the hemodynamic forces with the help of dedicated software (QStrain version 1.3.0.79; Medis, Leiden, the Netherlands).
Detailed description
In total 112 patients who underwent coronary artery bypass surgery (CABG) subjected to stress CMR examination on two separate occasions with both stressors; dobutamine and adenosine for assessment of myocardial ischemia as result of typical /atypical angina pectoris. The results from dobutamine (namely, detection of wall motion abnormalities) and adenosine stress CMR (namely, detection of perfusion abnormalities) will be compared with the values obtained from the measures of the hemodynamic forces of the LV (i.e., changes in the intraventricular pressures during systole and diastole). The dimensionless root mean square (FRMS) is computed over the entire heartbeat as a measure of the overall force amplitude. In addition, LV global longitudinal strain (GLS) and LV global circumferential strain (GCS) will be measured using a CMR feature tracking techniques. The expected results are as follows: Dobutamine wall motion analysis in combination with perfusion imaging has the highest diagnostic accuracy for the detection of ischemia in patients after bypass surgery and outperforms pure dobutamine wall motion or perfusion analysis and adenosine perfusion. Whereas, perfusion imaging with both stressors reflects the extent of ischemia more precisely than wall motion analysis. Nevertheless, assessment of hemodynamic forces adds to the diagnostic accuracy as well as the prognostic value of stress CMR in post-CABG patients, in whom stress testing with either or both stressors might fail to precisely define myocardial ischemia or reflect an associated subtle cardiac dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population are known to have coronary artery disease and underwent revascularization therapy via bypass surgery around 10 years before the initial CMR examination. Those presented with manifestations of recurrent post-CABG angina, with either typical or atypical presentation. Each patient had two CMR examinations on two occasions using both dobutamine and adenosine stress agents.
Key inclusion criteria (1 listed)
- Patients with established CAD and underwent coronary artery bypass graft surgery (CABG) performed around 10 years before the initial CMR examination. Who presented to CMR examination because of recurrent typical/ atypical angina.
Key exclusion criteria (2 listed)
- All patients that were not able to withstand the condition of CMR examination
- Patients who had contraindications to the stressor agents used in stress CMR were not included in the analysis (i.e. bronchial asthma, high degree heart-block)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of hard and soft cardiac events and their relation to initial positive or negative Stress-CMR-test.
Time frame: 1 year
Hard cardiac outcomes are defined defined as deaths that are attributed to coronary artery disease, and non-fatal myocardial infarction. While soft events are defined as angina, or repeat revascularization for progressive coronary artery disease.
2 secondary outcomes
Definition of the prognostic value of vasodilator stress and inotropic stress-CMR in patients with chronic CAD and a history of CABG.
Time frame: 1 year
Evaluation of the diagnostic accuracy of hemodynamic forces and assessment of the relationship to inducible wall motion abnormalities and perfusion defects.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Amr Youssef, MD study director
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 Coronary Artery 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 2 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 31 Jan 2020. 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 Ayat Abdelgalil, Msc. (+2 01144478313, soze2080@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of hard and soft cardiac events and their relation to initial positive or negative Stress-CMR-test. (time frame: 1 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 31 Jan 2020.