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Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179165
First Posted: August 11, 2010
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Volda Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
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.

Condition Intervention
Type 2 Diabetes Other: Diagnostic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Application in High Risk Groups of Recently Developed Noninvasive Methods in Diagnosing Coronary Heart Disease.A Community Based Study.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Prevalence of cardiac abnormalities/disease according to different examination modalities [ Time Frame: at primary examination ]

Secondary Outcome Measures:
  • 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

  • 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

  • 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)

  • Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI [ Time Frame: 4 months ]
    in exercise training group


Biospecimen Retention:   Samples Without DNA
Routine laboratory tests, parameters to caracterize diabetes controle, inflammatory markers.

Enrollment: 104
Actual Study Start Date: January 2011
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 2 diabetes age 40-75
Only one diagnostic/observational group
Other: Diagnostic
Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetes without known cardiac disease between 40 and 75 years of age
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179165


Locations
Norway
Volda Hospital HF
Volda, Norway, N-6100
Sponsors and Collaborators
Norwegian University of Science and Technology
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
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01179165     History of Changes
Other Study ID Numbers: 83FU18-09
First Submitted: July 30, 2010
First Posted: August 11, 2010
Last Update Posted: March 8, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases