Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study (CATCH)

August 16, 2019 updated by: The University of Hong Kong
The aim of this study is to determine the prevalence of myocardial ischaemia in asymptomatic high risk type 2 diabetic patients using stress cardiac MR and how many stress cardiac MR examinations are false positive.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Asymptomatic coronary artery disease (CAD) is highly prevalent (ie. 17-59%) in type 2 diabetic patients. In addition, cardiovascular disease remains the most common cause of death in type 2 diabetics. Previous trials using coronary computed tomography angiograms (CCTA) or nuclear myocardial perfusion imaging (MPI) to screen for asymptomatic coronary artery disease requiring intervention have been unsuccessful at reducing cardiovascular and all cause mortality when compared to optimised medical therapy where cardiovascular risk factors are treated in order to reduce cardiovascular complications. Possible reasons for this include, the choice of imaging modality, the intervention chosen (eg. bare metal stents vs drug eluting stents), patient cohort (eg. all diabetics vs high risk diabetics). Stress cardiac magnetic resonance (CMR) is ideally suited to assess this group of high risk patients as there is no radiation exposure and it allows a more complete analysis of the heart including the assessment of myocardial viability, cardiac systolic and diastolic function. The significance of this envisioned randomised controlled trial is firstly to investigate if stress CMR screening will reduce major adverse cardiovascular events including death. Secondly, a study using stress CMR has never been performed.

Study Type

Interventional

Enrollment (Actual)

63

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong

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

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Onset of type 2 diabetes at ≥30yrs old with no history of ketoacidosis
  • 60-80yrs old
  • Framingham Risk Score ≥20%

Exclusion Criteria:

  • Angina pectoris or chest discomfort
  • Stress test or coronary angiography within 2 years
  • Previous myocardial infarction (MI)
  • Previous coronary artery stenting or coronary artery bypass grafting
  • Any clinical indication or contraindication for stress testing
  • Any contraindication to stress CMR (eg. non-MRI compatible devices)
  • Contraindication to gadolinium based contrast agent (eg. Renal impairment with an estimated glomerular filtration rate (GFR) <30ml/min/1.73m2)
  • Life expectancy <2 years due to cancer or liver disease
  • Contraindication to dual antiplatelet therapy
  • Planned need for concomitant cardiac surgery
  • Refusal or inability to sign an informed consent.
  • Potential for non-compliance towards the requirements in the trial protocol
  • Unable to cover the costs of percutaneous coronary intervention (PCI) whether through government subsidies, etc

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stress Cardiac MR
Diagnostic test: Cardiac Magnetic Resonance
Screening of asymptomatic of high risk type 2 diabetic mellitus patients with stress cardiac magnetic resonance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of myocardial ischaemia
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of myocardial infarction
Time Frame: 1 year
1 year
Clinical predictors of silent ischaemia
Time Frame: 1 year
1 year
Major adverse cardiovascular events
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

Collaborators

Radiological Society of North America

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 10, 2017

Primary Completion (ACTUAL)

January 29, 2019

Study Completion (ACTUAL)

January 29, 2019

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (ACTUAL)

August 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 16, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW-17-168

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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