Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Diagnostic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetes age 40-75<br>Only one diagnostic/observational group | Other: Diagnostic<br>* Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of cardiac abnormalities/disease according to different examination modalities |  | at primary examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI. | Descriptive study; that is at baseline examination except substudy training group which will also be examined after 4 months of exercise training | at baseline | 
| Relationship between CFR in LAD and forearm FMD | Relationship between CFR in LAD and forearm FMD before and after 4 months of exercise training in diabetics. Substudy | 4 months | 
| Doppler echocardiographic findings related to clinical, laboratory and MRI findings | Special emphasis on new modalities as strain/strain rate at rest and stress. At baseline examination (no follow up) | at baseline | 
| Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI | in exercise training group | 4 months |