Trial record 5 of 1530 for:    Open Studies | "Coronary Artery Disease"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Bergen
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Mai Tone Lønnebakken, University of Bergen
ClinicalTrials.gov Identifier:
NCT01853527
First received: May 7, 2013
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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
Coronary Atherosclerosis
Myocardial Ischemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myocardial Ischemia in Non-obstructive Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Presence of myocardial ischemia by contrast stress echocardiography [ Time Frame: 15 minutes, during contrast stress echocardopgraphy ] [ Designated as safety issue: No ]
    Presence of delayed myocardial contrast enhancement during stress echocardiography


Secondary Outcome Measures:
  • Extent of myocardial ischemia by contrast stress echocardiography [ Time Frame: 15 minutes, during contrast stress echocardiography ] [ Designated as safety issue: No ]
    Numbers of left ventricular segments with delayed contrast enhancement during stress echocardiography


Biospecimen Retention:   Samples With DNA

Blood and urin test for biobank


Estimated Enrollment: 132
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853527

Contacts
Contact: Mai Tone Lønnebakken, MD phd +47 55972220 mai.lonnebakken@k2.uib.no

Locations
Norway
Department of Heart Disease, Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Mai Tone Lønnebakken, MD phd    +47 55972220    mai.lonnebakken@k2.uib.no   
Sub-Investigator: Eva Gerdts, MD phd         
Sub-Investigator: Terje H Larsen, MD phd         
Sub-Investigator: Ottar K Nygård, MD phd         
Sub-Investigator: Tone M Norekvål         
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Investigators
Principal Investigator: Mai Tone Lønnebakken, MD, phd University of Bergen
  More Information

No publications provided

Responsible Party: Mai Tone Lønnebakken, MD, phd, University of Bergen
ClinicalTrials.gov Identifier: NCT01853527     History of Changes
Other Study ID Numbers: 2012/2167b
Study First Received: May 7, 2013
Last Updated: May 10, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by 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
Atherosclerosis
Arteriosclerosis
Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014