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Completed

NCT Number: NCT03263728

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac magnetic resonance

Diagnostic Test

Screening of asymptomatic of high risk type 2 diabetic mellitus patients with stress cardiac magnetic resonance

Primary outcomes

  1. Prevalence of myocardial ischaemia

    Time frame: 1 year

Secondary outcomes

  1. Prevalence of myocardial infarction

    Time frame: 1 year

  2. Clinical predictors of silent ischaemia

    Time frame: 1 year

  3. Major adverse cardiovascular events

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Radiological Society of North America

Registry information

Acronym: CATCH

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2017
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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