Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Diagnostic

• Registration Number: NCT01179165
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-30
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-11
• Study Start: 2011-01
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 diabetes age 40-75	Diagnostic	Only one diagnostic/observational group

Primary Outcome Measures

Name	Time	Method
Prevalence of cardiac abnormalities/disease according to different examination modalities	at primary examination

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Volda Hospital HF; 🇳🇴 Volda, Norway