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Markers of Coronary Artery Disease During Exercise Testing (CADENCE)

This study is currently recruiting participants.
Verified September 2012 by Oslo University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01495091
First Posted: December 19, 2011
Last Update Posted: September 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Oslo University Hospital
  Purpose
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.

Condition
Coronary Artery Disease Cardiovascular Disease

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Markers of Coronary Artery Disease During Exercise Testing

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Coronary artery disease demonstrated by coronary angiography [ Time Frame: baseline ]

Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
Whole blood, serum.

Estimated Enrollment: 600
Study Start Date: December 2011
Estimated Study Completion Date: December 2040
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495091


Contacts
Contact: Arnljot Flaa, MD PhD +47 22119101 arnljot.flaa@gmail.com
Contact: Hilde Ulsaker, MD +47 22119261 hilde.ulsaker@gmail.com

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0407
Contact: Hilde Ulsaker, MD    +4722119442    hildeulsaker@gmail.com   
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
Study Chair: Arnljot Flaa, MD PhD Oslo University Hospital
Principal Investigator: Hilde Ulsaker, MD Oslo University Hospital and University of Oslo
Study Director: Eivind Berge, MD PhD Oslo University Hospital
Study Director: Ingebjørg Seljeflot, Professor PhD Oslo University Hospital and University of Oslo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01495091     History of Changes
Other Study ID Numbers: 2011/1938 (REK)
First Submitted: December 9, 2011
First Posted: December 19, 2011
Last Update Posted: September 12, 2012
Last Verified: September 2012

Keywords provided by Oslo University Hospital:
coronary artery disease
cardiovascular disease
exercise stress testing
biomarkers
NT-pro-BNP

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases