Clinical trial NCT04009421: Coronary Artery Plaque Burden in Stable Angina and Non-obstructive Coronary Artery Disease
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Plaque, Atherosclerotic
Keywords: coronary artery disease
plaque burden
prognosis
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2019-07-05
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular mortality and nonfatal acute myocardial infarction
timeFrame: 5 years
Secondary outcomes:
measure: All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures
timeFrame: 5 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Clinical Science, University of Bergen
Study officials:
affiliation: University of Bergen
name: Mai Tone Lønnebakken, MD phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berge CA, Eskerud I, Almeland EB, Larsen TH, Pedersen ER, Rotevatn S, Lonnebakken MT. Relationship between hypertension and non-obstructive coronary artery disease in chronic coronary syndrome (the NORIC registry). PLoS One. 2022 Jan 21;17(1):e0262290. doi: 10.1371/journal.pone.0262290. eCollection 2022.