Coronary Artery DiseaseCADENCENCT01495091
Markers of Coronary Artery Disease During Exercise Testing
An observational study of Coronary Artery Disease and Cardiovascular Disease, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Cardiovascular Disease
- How many people
- 327 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2011to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- Complete or partial bundle branch block.
- Digitoxin therapy.
- Pacemaker.
- Renal insufficiency (S-creatinine >150 micromol/L).
- Known pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Cardiovascular Disease
- Keywords
- coronary artery disease, cardiovascular disease, exercise stress testing, biomarkers, NT-pro-BNP
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery disease demonstrated by coronary angiography
Measured: baseline
Secondary outcomes (1)
Future cardiovascular morbidity and mortality
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.
Measured: Up to 29 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2017
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Arnljot Flaa, Oslo University Hospital
- Investigators
- Arnljot Flaa, MD PhD, Study chair, Oslo University HospitalIngebjørg Seljeflot, Professor PhD, Study director, Oslo University Hospital and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495091
- Sponsor's protocol ID
- 2011/1938 (REK)
- Acronym
- CADENCE
- Status last verified
- Sep 2022
- First submitted
- 9 Dec 2011
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35437054Cwikiel 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.
PubMed 28115916
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Coronary Artery Disease During Exercise Testing
- ClinicalTrials.gov ID
- NCT01495091
- Acronym / sponsor ID
- CADENCE / 2011/1938 (REK)
- Conditions
- Coronary Artery Disease, Cardiovascular Disease
- Keywords
- coronary artery disease, cardiovascular disease, exercise stress testing, biomarkers, NT-pro-BNP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Dec 2011
- Primary completion
- Oct 2017 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coronary artery disease demonstrated by coronary angiography
Time frame: baseline
1 secondary outcome
Future cardiovascular morbidity and mortality
Time frame: Up to 29 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Derived from this study: PubMed 35437054Hansen 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.
- Derived from this study: PubMed 28115916Cwikiel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnljot Flaa, MD PhD study chair
Oslo University Hospital
Ingebjørg Seljeflot, Professor PhD study director
Oslo University Hospital and University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Cardiovascular Disease, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary artery disease demonstrated by coronary angiography (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01495091, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.