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NCT01853527 Clinical Trial

Myocardial Ischemia in Non-obstructive Coronary Artery Disease

Myocardial Ischemia Clinical Trial

— MicroCAD  

Official title:
Myocardial Ischemia in Non-obstructive Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01853527
Other study ID # 2012/2167b
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2013
Est. completion date December 2017

Study information
Verified date November 2018
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to assess presence of myocardial ischemia by contrast stress echocardiography in patients with symptomatic non-obstructive coronary artery disease (CAD) by CT-coronary angiography, and the clinical, vascular, biochemical and genetic markers of myocardial ischemia in such patients.

Description:

Non-obstructive coronary artery disease (CAD) is particularly common in women and associated with reduced quality of life and increased cardiovascular morbidity and mortality. The project will recruit patients with angina pectoris and non-obstructive CAD by CT- coronary angiography for further imaging with contrast stress echocardiography for diagnosis of myocardial ischemia. Better characterization of patients with symptomatic non-obstructive CAD due to myocardial ischemia will be done by vascular assessment by tonometry, biochemical and genetic markers as well as quality of life questionnaire. This interdisciplinary project is expected to add new knowledge to the impact of multimodality cardiac imaging in improving diagnosis in patients with symptomatic non-obstructive CAD.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date December 2017
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria:

- Age >30 years

- Chest pain and or functional dyspnoea with a duration > 6 months

- Non-obstructive coronary artery disease detected by CT coronary angiography

Exclusion Criteria:

- Significant coronary artery stenosis or normal coronary arteries by CT coronary angiography

- Unstable coronary artery disease

- Significant valvular heart disease

- Mechanical valve prosthesis

- Significant arrhythmia

- Severly reduced pulmonary function (GOLD 3-4)

- Known allergy to ultrasound contrast agents

- Pregnancy

- Inability to sign informed consent to participate

- Other severe disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Department of Heart Disease, Haukeland University Hospital Bergen

Sponsors (2)
Lead Sponsor Collaborator
University of Bergen Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of myocardial ischemia by contrast stress echocardiography Presence of delayed myocardial contrast enhancement during stress echocardiography 15 minutes, during contrast stress echocardopgraphy
Secondary Extent of myocardial ischemia by contrast stress echocardiography Numbers of left ventricular segments with delayed contrast enhancement during stress echocardiography 15 minutes, during contrast stress echocardiography
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