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Active, Not Recruiting

NCT Number: NCT04009421

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Science, University of Bergen

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary artery plaque assessment by CT coronary angiography QAngio CT RE

Diagnostic Test

Assessment of segmental plaque volume and composition

Primary outcomes

  1. Cardiovascular mortality and nonfatal acute myocardial infarction

    Time frame: 5 years

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

Secondary outcomes

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

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Haukeland University Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Jul 5, 2019
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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