Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

March 7, 2017 updated by: Norwegian University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Volda, Norway, N-6100
        • Volda Hospital HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetes without known cardiac disease between 40 and 75 years of age

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 2 diabetes age 40-75
Only one diagnostic/observational group
Other: Diagnostic
Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of cardiac abnormalities/disease according to different examination modalities
Time Frame: at primary examination
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.
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
at baseline
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
4 months
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)
at baseline
Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI
Time Frame: 4 months
in exercise training group
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Volda Hospital

Investigators

  • Study Chair: Torstein L Hole, MD, PhD, Norwegian University of Science and Technology
  • Study Chair: Rune Wiseth, MD, PhD, Norwegian University of Science and Technology
  • Principal Investigator: Svein Hareide, MD, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 30, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (Estimate)

August 11, 2010

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83FU18-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Diagnostic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe