Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study (CATCH)
Primary Purpose
Diabetes Mellitus, Type 2, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cardiac Magnetic Resonance
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus, Type 2 focused on measuring Stress Cardiac Magnetic Resonance
Eligibility Criteria
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
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stress Cardiac MR
Arm Description
Outcomes
Primary Outcome Measures
Prevalence of myocardial ischaemia
Secondary Outcome Measures
Prevalence of myocardial infarction
Clinical predictors of silent ischaemia
Major adverse cardiovascular events
Full Information
NCT ID
NCT03263728
First Posted
August 24, 2017
Last Updated
August 16, 2019
Sponsor
The University of Hong Kong
Collaborators
Radiological Society of North America
1. Study Identification
Unique Protocol Identification Number
NCT03263728
Brief Title
Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study
Acronym
CATCH
Official Title
Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
January 29, 2019 (Actual)
Study Completion Date
January 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
Radiological Society of North America
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Coronary Artery Disease
Keywords
Stress Cardiac Magnetic Resonance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stress Cardiac MR
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac Magnetic Resonance
Intervention Description
Screening of asymptomatic of high risk type 2 diabetic mellitus patients with stress cardiac magnetic resonance
Primary Outcome Measure Information:
Title
Prevalence of myocardial ischaemia
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Prevalence of myocardial infarction
Time Frame
1 year
Title
Clinical predictors of silent ischaemia
Time Frame
1 year
Title
Major adverse cardiovascular events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
32234045
Citation
Ng MY, Zhou W, Vardhanabhuti V, Lee CH, Yu EYT, Wan EYF, Chan K, Yan AT, Ip TP, Yiu KH, Wintersperger BJ. Cardiac magnetic resonance for asymptomatic patients with type 2 diabetes and cardiovascular high risk (CATCH): a pilot study. Cardiovasc Diabetol. 2020 Mar 31;19(1):42. doi: 10.1186/s12933-020-01019-2.
Results Reference
derived
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Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study
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