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Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

This study is currently recruiting participants.
Verified December 2011 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
Volda Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01179165
First received: July 30, 2010
Last updated: December 16, 2011
Last verified: December 2011
History of Changes
  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.Coronary Heart Disease Prevalence Diagnosed With Coronary Flow Reserve (CFR), Tissue Doppler (TVI/TDI) and Cardiac MRI in a Group of Patients With Type 2 Diabetes Mellitus. A Community Based Study.

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI. [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    in exercise training group


Biospecimen Retention:   Samples Without DNA

Routine laboratory tests, parameters to caracterize diabetes controle, inflammatory markers.


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 2 diabetes Other: Diagnostic
Diagnostic

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179165

Contacts
Contact: Svein Hareide, MD (47)70105000 svein.hareide@helse-sunnmore.no
Contact: Torstein L Hole, MD, PhD (47)70105000 ext 5651 torstein.hole@helse-sunnmore.no

Locations
Norway
Volda Hospital HF Recruiting
Volda, Norway, N-6100
Contact: Svein Hareide, MD     +4770105000     svein.hareide@helse-sunnmore.no    
Contact: Torstein Hole, Md, PhD     +4770105000     torstein.hole@helse-sunnmore.no    
Principal Investigator: Svein Hareide, MD            
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

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01179165     History of Changes
Other Study ID Numbers: 83FU18-09
Study First Received: July 30, 2010
Last Updated: December 16, 2011
Health Authority: Norway: Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013