Coronary AtherosclerosisMicroCADNCT01853527
Myocardial Ischemia in Non-obstructive Coronary Artery Disease
An observational study of Coronary Atherosclerosis and Myocardial Ischemia, run by University of Bergen at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Atherosclerosis, Myocardial Ischemia
- How many people
- 132 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2013to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population include 132 patients with symptomatic angina pectoris and non-obstructive coronary artery disease detected by CT-coronary angiography
Who may be able to join
- Age >30 years
- Chest pain and or functional dyspnoea with a duration > 6 months
- Non-obstructive coronary artery disease detected by CT coronary angiography
Who cannot join
- 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)
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- Known allergy to ultrasound contrast agents
- Pregnancy
- Inability to sign informed consent to participate
- Other severe disease
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Heart Disease, Haukeland University Hospital
Bergen, 5021
About this study
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.
Read the 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.
- Conditions
- Coronary Atherosclerosis, Myocardial Ischemia
- Keywords
- CT coronary angiography, Contrast stress echocardiography, Arterial stiffness, Quality of life, Biochemical and genetic markers
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Presence of myocardial ischemia by contrast stress echocardiography
Presence of delayed myocardial contrast enhancement during stress echocardiography
Measured: 15 minutes, during contrast stress echocardopgraphy
Secondary outcomes (1)
Extent of myocardial ischemia by contrast stress echocardiography
Numbers of left ventricular segments with delayed contrast enhancement during stress echocardiography
Measured: 15 minutes, during contrast stress echocardiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Mai Tone Lønnebakken, University of Bergen
- Investigators
- Mai Tone Lønnebakken, MD, phd, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853527
- Sponsor's protocol ID
- 2012/2167b
- Acronym
- MicroCAD
- Status last verified
- Nov 2018
- First submitted
- 7 May 2013
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34258383Lonnebakken 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.
PubMed 31217997
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Ischemia in Non-obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01853527
- Acronym / sponsor ID
- MicroCAD / 2012/2167b
- Conditions
- Coronary Atherosclerosis, Myocardial Ischemia
- Keywords
- CT coronary angiography, Contrast stress echocardiography, Arterial stiffness, Quality of life, Biochemical and genetic markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population include 132 patients with symptomatic angina pectoris and non-obstructive coronary artery disease detected by CT-coronary angiography
Key inclusion criteria (3 listed)
- Age >30 years
- Chest pain and or functional dyspnoea with a duration > 6 months
- Non-obstructive coronary artery disease detected by CT coronary angiography
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Extent of myocardial ischemia by contrast stress echocardiography
Time frame: 15 minutes, during contrast stress echocardiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Derived from this study: PubMed 34258383Eskerud 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.
- Derived from this study: PubMed 31217997Lonnebakken 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai Tone Lønnebakken, MD, phd principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Atherosclerosis and Myocardial Ischemia, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of myocardial ischemia by contrast stress echocardiography (time frame: 15 minutes, during contrast stress echocardopgraphy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01853527, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.