Evaluating a new method for assessing blood flow in diabetic patients with heart disease
NUCLEuS: Evaluating DyNamic Myocardial Blood Flow QUantitation As a Cost Effective Care ModeL for DiabEtic Patients With Coronary Artery DiSease: A Randomized Controlled Trial
NA · National Heart Centre Singapore · NCT05343884
This study is testing a new way to check blood flow in diabetic patients with heart disease to see if it can find problems better than the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | National Heart Centre Singapore (other) |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05343884 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 300 diabetic patients who will be randomly assigned to receive either a dynamic myocardial perfusion imaging (MPI) strategy or a conventional MPI strategy. The study aims to track healthcare resource utilization and assess both short-term and long-term outcomes related to coronary artery disease. The dynamic MPI technique is expected to provide better detection of coronary atherosclerosis, particularly in diabetic patients, compared to conventional methods. Outcomes will include diagnostic failures, major adverse cardiovascular events, and quality of life assessments over a follow-up period of up to 36 months.
Who should consider this trial
Good fit: Ideal candidates for this study are diabetic patients without known coronary artery disease who are referred for myocardial perfusion imaging.
Not a fit: Patients with a history of coronary interventions, asthma, COPD, or those with cardiac devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate detection and management of coronary artery disease in diabetic patients, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise with dynamic myocardial perfusion imaging techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diabetic patients without known coronary artery disease referred for MPI Exclusion Criteria: * 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
Where this trial is running
Singapore
- National Heart Centre Singapore — Singapore, Singapore (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Diabetes Mellitus