Evaluating DyNamic Myocardial Blood Flow QUantitation As a Cost Effective Care ModeL for DiabEtic Patients With Coronary Artery DiSease (NUCLEuS)

April 19, 2022 updated by: National Heart Centre Singapore

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

  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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169609
        • Recruiting
        • National Heart Centre Singapore
        • Contact:
        • Principal Investigator:
          • Angela S. Koh, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dynamic myocardial perfusion imaging
Dynamic myocardial perfusion imaging is performed to obtain additional measurements of coronary blood flow, compared to conventional imaging.
Radiation: Myocardial perfusion imaging
Myocardial perfusion imaging
Other: Conventional myocardial perfusion imaging
Conventional myocardial perfusion imaging which is based on standard routine clinical myocardial perfusion imaging.
Radiation: Myocardial perfusion imaging
Myocardial perfusion imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary end-points
Time Frame: Up to 12 months
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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart Centre Singapore

Collaborators

National Medical Research Council (NMRC), Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/2780

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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