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Completed

NCT Number: NCT01495091

Markers of Coronary Artery Disease During Exercise Testing

The main purpose of this study is to examine whether changes in biomarkers during exercise are related to coronary artery disease demonstrated by coronary angiography or echocardiography.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0407, Norway

About this study

Chest pain/discomfort is a common patient complaint in patients referred to outpatient clinics and emergency departments. The initial goal of evaluation is to exclude potential life threatening conditions like coronary artery disease. Exercise stress testing is a widely available non-invasive test in patients with chest pain and suspected coronary artery disease. However, the sensitivity and specificity of the test is relatively low. Exercise seems to cause an increase in the secretion of B-type natriuretic peptide (BNP), and myocardial ischemia may lead to an even more pronounced increase. Investigators aim to examine whether changes in bloodborne biomarkers such as NT-pro-BNP during exercise may improve the accuracy of exercise stress testing in patients with chest pain/discomfort and a clinical suspicion of coronary artery disease. Also, investigators aim to examine whether changes in biomarkers during exercise are related to cardiac disease demonstrated by echocardiography.

It is known that sudden heavy physical load can trigger myocardial infarction, especially in untrained individuals. The underlying mechanisms are poorly understood and may partly be related to changes in inflammation and haemostasis in patients with coronary artery disease. By measuring markers of inflammation and haemostasis during exercise stress testing, investigators hope to gain new insights into mechanisms responsible for exercise-related myocardial infarction.

Investigators also aim to do a follow-up study to investigate whether results of the initial examinations can relate to future risk of cardiovascular morbidity and mortality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients referred to Oslo University Hospital Ullevål with chest pain/discomfort of unknown etiology and and a clinical suspicion of coronary artery disease.
  • Intermediate or high pre test probability of coronary artery disease.
  • Able to give informed, written consent.

Exclusion criteria

  • Not able to perform the exercise test.
  • Evidence of acute coronary syndrome.
  • Known coronary artery stenosis where exercise testing is contraindicated.
  • The presence of known moderate to severe valvular heart disease.
  • Known heart failure or obvious clinical signs of heart failure.
  • Ongoing atrial fibrillation or atrial flutter.
  • Complete or partial bundle branch block.
  • Digitoxin therapy.
  • Pacemaker.
  • Renal insufficiency (S-creatinine >150 micromol/L).
  • Known pregnancy.

Treatment and study plan

Primary outcomes

  1. Coronary artery disease demonstrated by coronary angiography

    Time frame: baseline

Secondary outcomes

  1. Future cardiovascular morbidity and mortality

    Time frame: Up to 29 years

    Investigators aim to do a follow-up study some years after enrollment to examine whether the results of the initial examinations can relate to future cardiovascular morbidity or mortality.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Acronym: CADENCE

Important dates

Study start
2011
Primary completion
2017
Study completion
2022
First posted
Dec 19, 2011
Registry last updated
Sep 22, 2022

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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