Coronary Artery DiseaseNUCLEuSNCT05343884
Evaluating DyNamic Myocardial Blood Flow QUantitation As a Cost Effective Care ModeL for DiabEtic Patients With Coronary Artery DiSease
A study testing Myocardial perfusion imaging in people with Coronary Artery Disease and Diabetes Mellitus, run by National Heart Centre Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus
- What is being tested?
- Myocardial perfusion imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Mar 2022to Mar 2026
- Phase
- Interventional
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patients without known coronary artery disease referred for MPI
Who cannot join
- History of percutaneous coronary intervention, coronary artery bypass graft surgery
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Presence of cardiac devices such as pacemakers and implantable cardiac defibrillators
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, 169609
Angela S. Koh, MBBS, 67048961, angela.koh.s.m@singhealth.com.sg
Angela S. Koh, MBBS
About this study
Official title: NUCLEuS: Evaluating DyNamic Myocardial Blood Flow QUantitation As a Cost Effective Care ModeL for DiabEtic Patients With Coronary Artery DiSease: A Randomized Controlled Trial
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.
Read the detailed 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
- 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.
- Biospecimen collection Fresh blood, urine and/or stool specimens will be collected for biochemistry, biomarkers and other profiles.
- 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.
- 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.
- 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
- 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.
- Biospecimen collection Fresh blood, urine and/or stool specimens will be collected for biochemistry, biomarkers and other profiles.
- 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.
- 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.
- Conventional myocardial perfusion imaging You will undergo conventional myocardial perfusion imaging which is based on standard routine clinical myocardial perfusion imaging.
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Being tested
- Myocardial perfusion imaging
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial perfusion imagingRadiation
Myocardial perfusion imaging
| Study group | Role | What they receive |
|---|---|---|
| Dynamic myocardial perfusion imaging | Other | Dynamic myocardial perfusion imaging is performed to obtain additional measurements of coronary blood flow, compared to conventional imaging. Receives: Radiation: Myocardial perfusion imaging |
| Conventional myocardial perfusion imaging | Other | Conventional myocardial perfusion imaging which is based on standard routine clinical myocardial perfusion imaging. Receives: Radiation: Myocardial perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Failure
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).
Measured: Up to 12 months
Secondary outcomes (1)
Secondary end-points
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start15 Mar 2022
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343884
- Sponsor's protocol ID
- 2021/2780
- Acronym
- NUCLEuS
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUCLEuS: Evaluating DyNamic Myocardial Blood Flow QUantitation As a Cost Effective Care ModeL for DiabEtic Patients With Coronary Artery DiSease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05343884
- Acronym / sponsor ID
- NUCLEuS / 2021/2780
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 Apr 2022 (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.
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.
Detailed 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
- 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.
- Biospecimen collection Fresh blood, urine and/or stool specimens will be collected for biochemistry, biomarkers and other profiles.
- 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.
- 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.
- 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
- 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.
- Biospecimen collection Fresh blood, urine and/or stool specimens will be collected for biochemistry, biomarkers and other profiles.
- 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.
- 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.
- Conventional myocardial perfusion imaging You will undergo conventional myocardial perfusion imaging which is based on standard routine clinical myocardial perfusion imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic myocardial perfusion imaging | Other | Radiation: Myocardial perfusion imagingDynamic myocardial perfusion imaging is performed to obtain additional measurements of coronary blood flow, compared to conventional imaging. |
| Conventional myocardial perfusion imaging | Other | Radiation: Myocardial perfusion imagingConventional myocardial perfusion imaging which is based on standard routine clinical myocardial perfusion imaging. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients without known coronary artery disease referred for MPI
Key exclusion criteria (4 listed)
- History of percutaneous coronary intervention, coronary artery bypass graft surgery
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Presence of cardiac devices such as pacemakers and implantable cardiac defibrillators
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 |
|---|---|---|
| Myocardial perfusion imagingMyocardial perfusion imaging | Radiation | Conventional myocardial perfusion imaging, Dynamic myocardial perfusion imaging |
Primary outcome
Diagnostic Failure
Time frame: Up to 12 months
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).
1 secondary outcome
Secondary end-points
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myocardial perfusion imaging in people with Coronary Artery Disease and Diabetes Mellitus, run by National Heart Centre Singapore at 1 site in Singapore.
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 25 Apr 2022. 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 Singapore. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Failure (time frame: Up to 12 months). 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 25 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.