Coronary Artery Plaque Burden in Stable Angina and Non-obstructive Coronary Artery Disease
November 28, 2023 updated by: Mai Tone Lønnebakken, University of Bergen
Covariates of Coronary Artery Plaque Burden and Composition by CT Coronary Angiography in Women and Men With Stable Angina and Non-obstructive Coronary Artery Disease - Analysis From the NORIC Registry
Non-obstructive coronary artery disease (CAD), particularly common in women, has been associated with impaired quality of life and risk of recurrent hospitalizations. Several studies have also demonstrated increased risk of incident acute coronary events and mortality.
The main objective of the project is to assess the association between coronary artery plaque features by coronary CT angiography and long term prognosis in a large unselected population undergoing CT coronary angiography due to stable angina and suspected myocardial ischemia from the Norwegian Registry for Invasive Cardiology (NORIC) diagnosed with non-obstructive CAD by coronary CT angiography.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients with stable angina and non-obstructive coronary artery disease by CT coronary angiography will be selected from the Norwegian Registry of Invasive Cardiology (NORIC).
This is a national quality control registry run and controlled by the Norwegian Institute of Public Health (www.fhi.no).
All CT coronary angiograms will be reanalyzed using advanced post-processing analysis software to assess coronary artery plaque burden, distribution and composition.
Through linking with the Norwegian Cardiovascular Disease Registry and the Cause of Death Registry (www.fhi.no)
we will be able to assess the association between long-term prognosis (5 years) and coronary artery plaque features.
Study Type
Observational
Enrollment (Estimated)
1400
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
-
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Bergen, Norway, 5021
- Department of Clinical Science, University of Bergen
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients from the NORIC registry undergoing CT coronary angiography due to chest pain and suspected myocardial ischemia and diagnosed with non-obstructive coronary artery disease between 2013-2017.
Description
Inclusion Criteria:
- Stable angina
- Non-obstructive coronary artery disease by CT coronary angiography defined as <50% stenosis (lumen diameter reduction)
Exclusion Criteria:
- Obstructive coronary artery disease
- Unstable angina
- Previous myocardial infarction, heart surgery or percutaneous coronary interventions
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 |
Intervention / Treatment |
|---|---|
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High and low coronary artery plaque burden
Patients with high plaque burden defined as plaque in >=4 segments of the coronary tree and low plaque burden as plaque in <4 segments of the coronary tree assessed by postprocessing of CT coronary angiography images and cardiovascular events and mortality.
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Assessment of segmental plaque volume and composition
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular mortality and nonfatal acute myocardial infarction
Time Frame: 5 years
|
Composite of deaths caused by cardiovascular disease and nonfatal acute myocardial infarction
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5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures
Time Frame: 5 years
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All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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 (Actual)
February 15, 2018
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
July 2, 2019
First Submitted That Met QC Criteria
July 3, 2019
First Posted (Actual)
July 5, 2019
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1573
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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