Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

NCT01179165 | Completed

• 1 other identifier: 83FU18-09
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Prevalence of cardiac abnormalities/disease according to different examination modalities

  at primary examination

Secondary Outcomes (4)

• Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI.

  at baseline

• Relationship between CFR in LAD and forearm FMD

  4 months

• Doppler echocardiographic findings related to clinical, laboratory and MRI findings

  at baseline

• Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI

  4 months

Study Arms (1)

Type 2 diabetes age 40-75

Only one diagnostic/observational group

Other: Diagnostic

Interventions

Diagnostic OTHER

Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI

Type 2 diabetes age 40-75

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Type 2 diabetes
• Age at diagnosis \> 30 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Volda Hospital: collaborator

Study Sites (1)

Volda Hospital HF

Volda, N-6100, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Torstein L Hole, MD, PhD

  Norwegian University of Science and Technology

  STUDY CHAIR

• Rune Wiseth, Md, Phd

  Norwegian University of Science and Technology

  STUDY CHAIR

• Svein Hareide, MD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: August 11, 2010
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 8, 2017

Record last verified: 2017-03

Locations

NO (1)