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

Sponsor

University of Bergen (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04009421

Collaborator

Haukeland University Hospital (Other)

1,400

Enrollment

Location

58.5

Anticipated Duration (Months)

23.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Plaque, Atherosclerotic	Diagnostic Test: Coronary artery plaque assessment by CT coronary angiography QAngio CT RE

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Feb 15, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Diagnostic Test: Coronary artery plaque assessment by CT coronary angiography QAngio CT RE Assessment of segmental plaque volume and composition

Arm

Intervention/Treatment

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.

Diagnostic Test: Coronary artery plaque assessment by CT coronary angiography QAngio CT RE

Assessment of segmental plaque volume and composition

Outcome Measures

Primary Outcome Measures

Cardiovascular mortality and nonfatal acute myocardial infarction [5 years]
Composite of deaths caused by cardiovascular disease and nonfatal acute myocardial infarction

Secondary Outcome Measures

All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures [5 years]
All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures