Evaluating DyNamic Myocardial Blood Flow QUantitation As a Cost Effective Care ModeL for DiabEtic Patients With Coronary Artery DiSease
NCT ID: NCT05343884
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2022-03-15
2026-03-31
Brief Summary
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Detailed Description
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Outcomes:
Short term outcomes:
* The primary end-point is diagnostic failure, defined as unnecessary coronary angiography (absence of ≥50% stenosis in ≥1 coronary arteries) or any additional coronary testing (example, computed tomography of coronary arteries).
* Secondary end-points are post-test referral to coronary angiography, coronary revascularization (percutaneous coronary intervention or coronary artery bypass surgery), or escalation in anti-anginal medication.
Long term outcomes:
* Major adverse cardiovascular events to be measured include cardiac mortality, acute myocardial infarction, unstable angina, any revascularization, up till 36 months.
* Quality of life (QOL): Using Seattle Angina Questionnaire (SAQ) and EuroQOL-5D-3L, we will measure the difference in QOL measured at baseline and follow-up within each diagnostic strategy, and compared between both strategies.
The differences in healthcare resource utilization and associated costs will be compared between the two diagnostic strategies.
Group A
Visit 1 and/or Visit 2:
Baseline procedures
1. Cardiovascular measurements:
Non-invasive brachial blood pressure machine Echocardiogram Standard transthoracic echocardiographic examination will be performed according to established laboratory practice using standard commercially available machines.
Resting electrocardiography will be performed to ascertain sinus rhythm.
2. Biospecimen collection Fresh blood, urine and/or stool specimens will be collected for biochemistry, biomarkers and other profiles.
3. Musculoskeletal and Physical Analysis Participants will undergo focused examinations that include measurement of height, weight, body mass index, waist circumference, body composition analysis and handgrip strength.
4. Questionnaires You will be interviewed by our study coordinator regarding your health condition and other questions related to your health, physical activity and lifestyle and other questionnaires.
5. Dynamic myocardial perfusion imaging Dynamic myocardial perfusion imaging is performed to obtain additional measurements of coronary blood flow, compared to conventional imaging.
Group B
Visit 1 and/or Visit 2:
Baseline procedures
1. Cardiovascular measurements:
Non-invasive brachial blood pressure machine Echocardiogram Standard transthoracic echocardiographic examination will be performed according to established laboratory practice using standard commercially available machines.
Resting electrocardiography will be performed to ascertain sinus rhythm.
2. Biospecimen collection Fresh blood, urine and/or stool specimens will be collected for biochemistry, biomarkers and other profiles.
3. Musculoskeletal and Physical Analysis Participants will undergo focused examinations that include measurement of height, weight, body mass index, waist circumference, body composition analysis and handgrip strength.
4. Questionnaires You will be interviewed by our study coordinator regarding your health condition and other questions related to your health, physical activity and lifestyle and other questionnaires.
5. Conventional myocardial perfusion imaging You will undergo conventional myocardial perfusion imaging which is based on standard routine clinical myocardial perfusion imaging.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Dynamic myocardial perfusion imaging
Dynamic myocardial perfusion imaging is performed to obtain additional measurements of coronary blood flow, compared to conventional imaging.
Myocardial perfusion imaging
Myocardial perfusion imaging
Conventional myocardial perfusion imaging
Conventional myocardial perfusion imaging which is based on standard routine clinical myocardial perfusion imaging.
Myocardial perfusion imaging
Myocardial perfusion imaging
Interventions
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Myocardial perfusion imaging
Myocardial perfusion imaging
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Asthma
* Chronic obstructive pulmonary disease (COPD)
* Presence of cardiac devices such as pacemakers and implantable cardiac defibrillators
21 Years
90 Years
ALL
No
Sponsors
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National Medical Research Council (NMRC), Singapore
OTHER_GOV
National Heart Centre Singapore
OTHER
Responsible Party
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Locations
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National Heart Centre Singapore
Singapore, , Singapore
Countries
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Facility Contacts
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Other Identifiers
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2021/2780
Identifier Type: -
Identifier Source: org_study_id
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