Myocardial Ischemia in Non-obstructive Coronary Artery Disease (MicroCAD)

November 5, 2018 updated by: Mai Tone Lønnebakken, University of Bergen
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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Department of Heart Disease, Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population include 132 patients with symptomatic angina pectoris and non-obstructive coronary artery disease detected by CT-coronary angiography

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Angina pectoris, non-obstructive CAD
Contrast stress echocardiography will be performed in patients with angina pectoris and non-obstructive CAD on CT-angiography to detect presence of myocardial ischemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of myocardial ischemia by contrast stress echocardiography
Time Frame: 15 minutes, during contrast stress echocardopgraphy
Presence of delayed myocardial contrast enhancement during stress echocardiography
15 minutes, during contrast stress echocardopgraphy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of myocardial ischemia by contrast stress echocardiography
Time Frame: 15 minutes, during contrast stress echocardiography
Numbers of left ventricular segments with delayed contrast enhancement during stress echocardiography
15 minutes, during contrast stress echocardiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Haukeland University Hospital

Investigators

  • Principal Investigator: Mai Tone Lønnebakken, MD, phd, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/2167b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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