NCT03263728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

August 24, 2017

Last Update Submit

August 16, 2019

Conditions

Keywords

Stress Cardiac Magnetic Resonance

Outcome Measures

Primary Outcomes (1)

  • Prevalence of myocardial ischaemia

    1 year

Secondary Outcomes (3)

  • Prevalence of myocardial infarction

    1 year

  • Clinical predictors of silent ischaemia

    1 year

  • Major adverse cardiovascular events

    1 year

Study Arms (1)

Stress Cardiac MR

EXPERIMENTAL
Diagnostic Test: Cardiac Magnetic Resonance

Interventions

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

Stress Cardiac MR

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Coronary Artery Disease

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 28, 2017

Study Start

August 10, 2017

Primary Completion

January 29, 2019

Study Completion

January 29, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations