Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05343884 |
Other study ID # |
2021/2780 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 15, 2022 |
Est. completion date |
March 2026 |
Study information
Verified date |
April 2022 |
Source |
National Heart Centre Singapore |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This will be a prospective randomized clinical trial comprising of n=300 diabetic patients,
randomized to either dynamic (n=150) or conventional MPI (n=150) strategy. Healthcare
resources utilization of each patient will be tracked. Patients will be followed up for short
term outcomes and for long term outcomes.
Description:
Diabetes mellitus poses unique problems to detection and management of coronary
atherosclerosis. Among the diabetics, certain spectrums of coronary atherosclerosis may be
missed on conventional myocardial perfusion imaging, such as early coronary microvascular
dysfunction. On the other spectrum, advanced coronary atherosclerosis may result in balanced
ischemia, recording falsely negative results on conventional myocardial perfusion imaging.
These uncertainties either lead to more downstream testing or under-detection resulting in
higher risks of adverse outcomes. Compared to conventional myocardial perfusion imaging
(MPI), dynamic MPI quantitation is a new validated technique that provides additional
quantitation across the entire spectrum of coronary atherosclerosis.
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.