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

Coronary Artery Disease Clinical Trial

— CATCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263728
• Other study ID #: UW-17-168
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: January 29, 2019

Study information

• Verified date: August 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 29, 2019
• Est. primary completion date: January 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Diabetes Mellitus, Type 2

Intervention

Diagnostic Test:
• Cardiac Magnetic Resonance
Screening of asymptomatic of high risk type 2 diabetic mellitus patients with stress cardiac magnetic resonance

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Radiological Society of North America

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of myocardial ischaemia		1 year
Secondary	Prevalence of myocardial infarction		1 year
Secondary	Clinical predictors of silent ischaemia		1 year
Secondary	Major adverse cardiovascular events		1 year