Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

NCT ID: NCT01179165

Last Updated: 2017-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Type 2 diabetes age 40-75

Only one diagnostic/observational group

Diagnostic

Intervention Type OTHER

Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI

Interventions

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Diagnostic

Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI

Intervention Type OTHER

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Volda Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torstein L Hole, MD, PhD

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Rune Wiseth, Md, Phd

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Svein Hareide, MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Volda Hospital HF

Volda, , Norway

Site Status

Countries

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Norway

Other Identifiers

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83FU18-09

Identifier Type: -

Identifier Source: org_study_id

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