Markers of Coronary Artery Disease During Exercise Testing

NCT ID: NCT01495091

Last Updated: 2022-09-22

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

COMPLETED

Total Enrollment

327 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2022-03-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Cardiovascular Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Arnljot Flaa

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arnljot Flaa, MD PhD

Role: STUDY_CHAIR

Oslo University Hospital

Ingebjørg Seljeflot, Professor PhD

Role: STUDY_DIRECTOR

Oslo University Hospital and University of Oslo

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 35437054 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28115916 (View on PubMed)

Other Identifiers

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2011/1938 (REK)

Identifier Type: -

Identifier Source: org_study_id

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