Markers of Coronary Artery Disease During Exercise Testing (CADENCE)
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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 |
- Coronary artery disease demonstrated by coronary angiography [ Time Frame: baseline ] [ Designated as safety issue: No ]
- 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) |
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 |
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.
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| Contact: Arnljot Flaa, MD PhD | +47 22119101 | arnljot.flaa@gmail.com |
| Contact: Hilde Ulsaker, MD | +47 22119261 | hilde.ulsaker@gmail.com |
| Norway | |
| Oslo University Hospital | Recruiting |
| Oslo, Norway, 0407 | |
| Contact: Hilde Ulsaker, MD +4722119442 hildeulsaker@gmail.com | |
| 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 Myocardial Ischemia Coronary Disease |
Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013