Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179165
• Other study ID #: 83FU18-09
• Status: Completed
• Phase: N/A
• First received: July 30, 2010
• Last updated: March 7, 2017
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Type 2 Diabetes

Intervention

Other:
• Diagnostic
Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI

Locations

Country	Name	City	State
Norway	Volda Hospital HF	Volda

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Volda Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of cardiac abnormalities/disease according to different examination modalities		at primary examination
Secondary	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	at baseline
Secondary	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	4 months
Secondary	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)	at baseline
Secondary	Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI	in exercise training group	4 months