CClinicalTrials.gg
CompletedNCT01179165Updated Mar 8, 2017

Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

An observational study in Type 2 Diabetes, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-03-08.

Sponsored by Norwegian University of Science and Technology · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
104
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 104 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
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

Inclusion criteria

  • Type 2 diabetes
  • Age at diagnosis > 30 years
  • Age at inclusion 40-75 years

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
104 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Type 2 diabetes age 40-75

    Only one diagnostic/observational group

    Other: Diagnostic

Interventions

  • OtherDiagnostic

    Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI

06

What researchers measure

Primary outcomes

  1. Prevalence of cardiac abnormalities/disease according to different examination modalities

    Time frame: at primary examination

Secondary outcomes

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

    Descriptive study; that is at baseline examination except substudy training group which will also be examined after 4 months of exercise training

    Time frame: at baseline

  2. Relationship between CFR in LAD and forearm FMD

    Relationship between CFR in LAD and forearm FMD before and after 4 months of exercise training in diabetics. Substudy

    Time frame: 4 months

  3. Doppler echocardiographic findings related to clinical, laboratory and MRI findings

    Special emphasis on new modalities as strain/strain rate at rest and stress. At baseline examination (no follow up)

    Time frame: at baseline

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

    in exercise training group

    Time frame: 4 months

07

Study locations

1 site
  • Volda Hospital HF
    Volda, N-6100, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01179165
Lead sponsor
Norwegian University of Science and Technology
Collaborators
Volda Hospital
Responsible party
Sponsor
First posted
Aug 11, 2010
Start date
Jan 2011
Primary completion
Sep 2013
Completion
Dec 2013
Last update
Mar 8, 2017

Study contacts

Torstein L Hole, MD, PhD
study chair · Norwegian University of Science and Technology
Rune Wiseth, Md, Phd
study chair · Norwegian University of Science and Technology
Svein Hareide, MD
principal investigator · Norwegian University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion