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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04009421
• Other study ID #: 1573
• Status: Active, not recruiting
• Start date: February 15, 2018
• Est. completion date: December 2028

Study information

• Verified date: November 2023
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1400
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Plaque, Atherosclerotic

Intervention

Diagnostic Test:
• Coronary artery plaque assessment by CT coronary angiography QAngio CT RE
Assessment of segmental plaque volume and composition

Locations

Country	Name	City	State
Norway	Department of Clinical Science, University of Bergen	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular mortality and nonfatal acute myocardial infarction	Composite of deaths caused by cardiovascular disease and nonfatal acute myocardial infarction	5 years
Secondary	All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures	All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures	5 years