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

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ClinicalTrials.gov Identifier: NCT01853527
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Mai Tone Lønnebakken, University of Bergen

Brief 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.

Condition or disease
Coronary Atherosclerosis Myocardial Ischemia

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
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myocardial Ischemia in Non-obstructive Coronary Artery Disease
Study Start Date : April 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Blood and urin test for biobank


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853527


Locations
Norway
Department of Heart Disease, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Investigators
Principal Investigator: Mai Tone Lønnebakken, MD, phd University of Bergen

Responsible Party: Mai Tone Lønnebakken, MD, phd, University of Bergen
ClinicalTrials.gov Identifier: NCT01853527     History of Changes
Other Study ID Numbers: 2012/2167b
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Keywords provided by Mai Tone Lønnebakken, University of Bergen:
CT coronary angiography
Contrast stress echocardiography
Arterial stiffness
Quality of life
Biochemical and genetic markers

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes