Clinical trial NCT01853527: Myocardial Ischemia in Non-obstructive Coronary Artery Disease
Official title: Myocardial Ischemia in Non-obstructive Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Atherosclerosis
Myocardial Ischemia
Keywords: CT coronary angiography
Contrast stress echocardiography
Arterial stiffness
Quality of life
Biochemical and genetic markers
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2013-05-15
Enrollment: 132
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: Presence of myocardial ischemia by contrast stress echocardiography
timeFrame: 15 minutes, during contrast stress echocardopgraphy
Secondary outcomes:
measure: Extent of myocardial ischemia by contrast stress echocardiography
timeFrame: 15 minutes, during contrast stress echocardiography
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Heart Disease, Haukeland University Hospital
Study officials:
affiliation: University of Bergen
name: Mai Tone Lønnebakken, MD, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eskerud I, Gerdts E, Larsen TH, Simon J, Maurovich-Horvat P, Lonnebakken MT. Total coronary atherosclerotic plaque burden is associated with myocardial ischemia in non-obstructive coronary artery disease. Int J Cardiol Heart Vasc. 2021 Jun 30;35:100831. doi: 10.1016/j.ijcha.2021.100831. eCollection 2021 Aug.
citation: Lonnebakken MT, Eskerud I, Larsen TH, Midtbo HB, Kokorina MV, Gerdts E. Impact of aortic stiffness on myocardial ischaemia in non-obstructive coronary artery disease. Open Heart. 2019 May 4;6(1):e000981. doi: 10.1136/openhrt-2018-000981. eCollection 2019.