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Coronary Artery DiseaseNCT04009421

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

An observational study of Coronary Artery Disease and Plaque, Atherosclerotic, run by University of Bergen at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coronary artery plaque assessment by CT coronary angiography QAngio CT RE
How many people
1,400 participants
Where
1 siteNorway
Study dates
15 Feb 2018to Dec 2028
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Department of Clinical Science, University of Bergen

    Bergen, 5021

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
Coronary artery plaque assessment by CT coronary angiography QAngio CT RE
Keywords
coronary artery disease, plaque burden, prognosis
Medical subject headings
Coronary Artery Disease, Plaque, Atherosclerotic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary artery plaque assessment by CT coronary angiography QAngio CT REDiagnostic test

    Assessment of segmental plaque volume and composition

Study groups in NCT04009421
Study groupRoleWhat they receive
High and low coronary artery plaque burdenPatients 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.
Receives: Diagnostic Test: Coronary artery plaque assessment by CT coronary angiography QAngio CT RE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular mortality and nonfatal acute myocardial infarction

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

    Measured: 5 years

Secondary outcomes (1)

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

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start15 Feb 2018
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,400 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04009421
Sponsor's protocol ID
1573
Status last verified
Nov 2023
First submitted
2 Jul 2019
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40645670

  • 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.

    PubMed 40521640

  • 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.

    PubMed 38356931

  • 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.

    PubMed 35061769

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Plaque, Atherosclerotic, run by University of Bergen at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular mortality and nonfatal acute myocardial infarction (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04009421, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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