Markers of Coronary Artery Disease During Exercise Testing (CADENCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Oslo University Hospital
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01495091
First received: December 9, 2011
Last updated: September 11, 2012
Last verified: September 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Future cardiovascular morbidity and mortality [ Time Frame: Up to 29 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01495091     History of Changes
Other Study ID Numbers: 2011/1938 (REK)
Study First Received: December 9, 2011
Last Updated: September 11, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014