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Clinical Trials/NCT01179165
NCT01179165
Completed
N/A

Application in High Risk Groups of Recently Developed Noninvasive Methods in Diagnosing Coronary Heart Disease.A Community Based Study.

Norwegian University of Science and Technology1 site in 1 country104 target enrollmentJanuary 2011
ConditionsType 2 Diabetes

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Norwegian University of Science and Technology
Enrollment
104
Locations
1
Primary Endpoint
Prevalence of cardiac abnormalities/disease according to different examination modalities
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to investigate the prevalence of cardiac disease/coronary artery disease and diagnostic yield of different non-invasive methods in patients with type 2 diabetes 40-75 years of age at examination. Exercise tests, Doppler echocardiographic examination with Tissue Velocity Imaging, stress Echocardiography, transthoracic Doppler of coronary arteries with coronary flow reserve, and cardiac MRI with late enhancement at rest, and perfusion after vasodilatation stress will be used in the study. A subpopulation will in addition measure forearm vasodilation(FMD) and CFR before and after 4 months of exercise training.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
December 2013
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Type 2 diabetes
  • Age at diagnosis \> 30 years
  • Age at inclusion 40-75 years

Exclusion Criteria

  • Angina pectoris
  • Coronary angiography/stress-test diagnostic of coronary artery disease last 3 years
  • Previous myocardial infarction, coronary bypass operation/PCI or heart failure
  • Clinical indication for stress -testing
  • Active bronchospasm excluding use of adenosine
  • eGFR \< 30 ml/min/m2
  • short estimated life expectancy due to cancer, chronic liver/renal diseases

Outcomes

Primary Outcomes

Prevalence of cardiac abnormalities/disease according to different examination modalities

Time Frame: at primary examination

Secondary Outcomes

  • Relationship between CFR in LAD and forearm FMD(4 months)
  • Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI.(at baseline)
  • Doppler echocardiographic findings related to clinical, laboratory and MRI findings(at baseline)
  • Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI(4 months)

Study Sites (1)

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