Diabetes Mellitus, Type 2CATCHNCT03263728
Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study
A study testing Cardiac Magnetic Resonance in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Coronary Artery Disease
- What is being tested?
- Cardiac Magnetic Resonance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Aug 2017to 29 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Onset of type 2 diabetes at ≥30yrs old with no history of ketoacidosis
- 60-80yrs old
- Framingham Risk Score ≥20%
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Coronary Artery Disease
- Being tested
- Cardiac Magnetic Resonance
- Keywords
- Stress Cardiac Magnetic Resonance
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic ResonanceDiagnostic test
Screening of asymptomatic of high risk type 2 diabetic mellitus patients with stress cardiac magnetic resonance
| Study group | Role | What they receive |
|---|---|---|
| Stress Cardiac MR | Experimental | Not described Receives: Diagnostic Test: Cardiac Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of myocardial ischaemia
Measured: 1 year
Secondary outcomes (3)
Prevalence of myocardial infarction
Measured: 1 year
Clinical predictors of silent ischaemia
Measured: 1 year
Major adverse cardiovascular events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start10 Aug 2017
- Primary completion29 Jan 2019
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263728
- Sponsor's protocol ID
- UW-17-168
- Acronym
- CATCH
- Status last verified
- Aug 2019
- First submitted
- 24 Aug 2017
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32234045
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study
- ClinicalTrials.gov ID
- NCT03263728
- Acronym / sponsor ID
- CATCH / UW-17-168
- Conditions
- Diabetes Mellitus, Type 2, Coronary Artery Disease
- Keywords
- Stress Cardiac Magnetic Resonance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Radiological Society of North America
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress Cardiac MR | Experimental | Diagnostic Test: Cardiac Magnetic Resonance |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Onset of type 2 diabetes at ≥30yrs old with no history of ketoacidosis
- 60-80yrs old
- Framingham Risk Score ≥20%
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Magnetic ResonanceScreening of asymptomatic of high risk type 2 diabetic mellitus patients with stress cardiac magnetic resonance | Diagnostic test | Stress Cardiac MR |
Primary outcome
Prevalence of myocardial ischaemia
Time frame: 1 year
3 secondary outcomes
Prevalence of myocardial infarction
Time frame: 1 year
Clinical predictors of silent ischaemia
Time frame: 1 year
Major adverse cardiovascular events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Derived from this study: PubMed 32234045Ng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Magnetic Resonance in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of myocardial ischaemia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03263728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.