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NCT Number: NCT01179165

Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Volda Hospital HF

Volda, N-6100, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic

Other

Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI

Primary outcomes

  1. Prevalence of cardiac abnormalities/disease according to different examination modalities

    Time frame: at primary examination

Secondary outcomes

  1. Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI.

    Time frame: at baseline

    Descriptive study; that is at baseline examination except substudy training group which will also be examined after 4 months of exercise training

  2. Relationship between CFR in LAD and forearm FMD

    Time frame: 4 months

    Relationship between CFR in LAD and forearm FMD before and after 4 months of exercise training in diabetics. Substudy

  3. Doppler echocardiographic findings related to clinical, laboratory and MRI findings

    Time frame: at baseline

    Special emphasis on new modalities as strain/strain rate at rest and stress. At baseline examination (no follow up)

  4. Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI

    Time frame: 4 months

    in exercise training group

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Volda Hospital

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 11, 2010
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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