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

NCT04009421 | Active Not Recruiting

• 1 other identifier: 1573
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Plaque, Atherosclerotic

Keywords

coronary artery disease; plaque burden; prognosis

Outcome Measures

Primary Outcomes (1)

• Cardiovascular mortality and nonfatal acute myocardial infarction

  Composite of deaths caused by cardiovascular disease and nonfatal acute myocardial infarction

  5 years

Secondary Outcomes (1)

• All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures

  5 years

Study Arms (1)

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

Interventions

Coronary artery plaque assessment by CT coronary angiography QAngio CT RE DIAGNOSTIC_TEST

Assessment of segmental plaque volume and composition

High and low coronary artery plaque burden

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Stable angina
• Non-obstructive coronary artery disease by CT coronary angiography defined as \<50% stenosis (lumen diameter reduction)

You may not qualify if:

• Obstructive coronary artery disease
• Unstable angina
• Previous myocardial infarction, heart surgery or percutaneous coronary interventions

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Department of Clinical Science, University of Bergen

Bergen, 5021, Norway

Location

Related Publications (4)

• Hondros CAB, Hanseth S, Solvik M, Pedersen EKR, Khan I, Hovland S, Larsen TH, Lonnebakken MT. Age-stratified differences in coronary artery plaque phenotypes in women and men with non-obstructive coronary artery disease. Open Heart. 2025 Jul 11;12(2):e003371. doi: 10.1136/openhrt-2025-003371.

  PMID: 40645670 DERIVED

• Khan I, Hondros CAB, Hanseth S, Pedersen ER, Hovland S, Larsen TH, Lonnebakken MT. Epicardial adipose tissue volume, compositional plaque progression, and vulnerability in nonobstructive coronary artery disease. Coron Artery Dis. 2025 Nov 1;36(7):580-586. doi: 10.1097/MCA.0000000000001539. Epub 2025 Jun 17.

  PMID: 40521640 DERIVED

• Hondros CAB, Khan I, Solvik M, Hanseth S, Pedersen EKR, Hovland S, Larsen TH, Lonnebakken MT. Compositional plaque progression in women and men with non-obstructive coronary artery disease. Int J Cardiol Heart Vasc. 2024 Feb 7;51:101352. doi: 10.1016/j.ijcha.2024.101352. eCollection 2024 Apr.

  PMID: 38356931 DERIVED

• 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.

  PMID: 35061769 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mai Tone Lønnebakken, MD phd

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: February 15, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

NO (1)