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Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01179165
Enrollment
104
Registered
2010-08-11
Start date
2011-01-31
Completion date
2013-12-31
Last updated
2017-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

OTHERDiagnostic

Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI

Sponsors

Volda Hospital
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Prevalence of cardiac abnormalities/disease according to different examination modalitiesat primary examination

Secondary

MeasureTime frameDescription
Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI.at baselineDescriptive study; that is at baseline examination except substudy training group which will also be examined after 4 months of exercise training
Relationship between CFR in LAD and forearm FMD4 monthsRelationship between CFR in LAD and forearm FMD before and after 4 months of exercise training in diabetics. Substudy
Doppler echocardiographic findings related to clinical, laboratory and MRI findingsat baselineSpecial 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 MRI4 monthsin exercise training group

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026