Evaluating DyNamic Myocardial Blood Flow QUantitation As a Cost Effective Care ModeL for DiabEtic Patients With Coronary Artery DiSease
NUCLEuS
NUCLEuS: Evaluating DyNamic Myocardial Blood Flow QUantitation As a Cost Effective Care ModeL for DiabEtic Patients With Coronary Artery DiSease: A Randomized Controlled Trial
1 other identifier
interventional
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Mar 2022
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2022
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedApril 25, 2022
April 1, 2022
3 years
March 15, 2022
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Up to 12 months
Secondary Outcomes (1)
Secondary end-points
Up to 12 months
Study Arms (2)
Dynamic myocardial perfusion imaging
OTHERDynamic myocardial perfusion imaging is performed to obtain additional measurements of coronary blood flow, compared to conventional imaging.
Conventional myocardial perfusion imaging
OTHERConventional myocardial perfusion imaging which is based on standard routine clinical myocardial perfusion imaging.
Interventions
Myocardial perfusion imaging
Eligibility Criteria
You may qualify if:
- Diabetic patients without known coronary artery disease referred for MPI
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Heart Centre Singapore
Singapore, 169609, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
April 25, 2022
Study Start
March 15, 2022
Primary Completion
March 1, 2025
Study Completion
March 1, 2026
Last Updated
April 25, 2022
Record last verified: 2022-04