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

NCT ID: NCT04009421

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-15

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Plaque, Atherosclerotic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Coronary artery plaque assessment by CT coronary angiography QAngio CT RE

Intervention Type DIAGNOSTIC_TEST

Assessment of segmental plaque volume and composition

Interventions

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Coronary artery plaque assessment by CT coronary angiography QAngio CT RE

Assessment of segmental plaque volume and composition

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Mai Tone Lønnebakken

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mai Tone Lønnebakken, MD phd

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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Department of Clinical Science, University of Bergen

Bergen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 40645670 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40521640 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38356931 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35061769 (View on PubMed)

Other Identifiers

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1573

Identifier Type: -

Identifier Source: org_study_id