Clinical trial NCT01495091: Markers of Coronary Artery Disease During Exercise Testing
Official title: Markers of Coronary Artery Disease During Exercise Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Cardiovascular Disease
Keywords: coronary artery disease
cardiovascular disease
exercise stress testing
biomarkers
NT-pro-BNP
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2011-12-19
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from patients with chest pain/discomfort referred for exercise stress testing at Oslo University Hospital, including patients with acute chest pain referred to the emergency department, and referrals to the outpatient clinic.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Coronary artery disease demonstrated by coronary angiography
timeFrame: baseline
Secondary outcomes:
measure: Future cardiovascular morbidity and mortality
timeFrame: Up to 29 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Arnljot Flaa, MD PhD
role: STUDY_CHAIR
affiliation: Oslo University Hospital and University of Oslo
name: Ingebjørg Seljeflot, Professor PhD
role: STUDY_DIRECTOR
References:
citation: Hansen CH, Cwikiel J, Bratseth V, Arnesen H, Flaa A, Seljeflot I. Effect of Revascularization on Exercise-Induced Changes in Cardiac and Prothrombotic Biomarkers in Patients with Coronary Artery Disease. Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221094029. doi: 10.1177/10760296221094029.
citation: Cwikiel J, Seljeflot I, Berge E, Arnesen H, Wachtell K, Ulsaker H, Flaa A. Pro-coagulant activity during exercise testing in patients with coronary artery disease. Thromb J. 2017 Jan 19;15:3. doi: 10.1186/s12959-016-0127-8. eCollection 2017.