Coronary Artery Plaque Burden in Stable Angina and Non-obstructive Coronary Artery Disease

Active, not recruiting

• Conditions: Coronary Artery Disease; Plaque, Atherosclerotic
• Interventions: Diagnostic Test: Coronary artery plaque assessment by CT coronary angiography QAngio CT RE

• Registration Number: NCT04009421
• Lead Sponsor: University of Bergen

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.

Study Timeline

• Study Start: 2018-02-15
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High and low coronary artery plaque burden	Coronary artery plaque assessment by CT coronary angiography QAngio CT RE	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.

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality and nonfatal acute myocardial infarction	5 years	Composite of deaths caused by cardiovascular disease and nonfatal acute myocardial infarction

Secondary Outcome Measures

Name	Time	Method
All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures	5 years	All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures

Trial Locations

Locations (1)

Department of Clinical Science, University of Bergen; 🇳🇴 Bergen, Norway