NCT01495091

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
327

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

5.8 years

First QC Date

December 9, 2011

Last Update Submit

September 19, 2022

Conditions

Keywords

coronary artery diseasecardiovascular diseaseexercise stress testingbiomarkersNT-pro-BNP

Outcome Measures

Primary Outcomes (1)

  • Coronary artery disease demonstrated by coronary angiography

    baseline

Secondary Outcomes (1)

  • Future cardiovascular morbidity and mortality

    Up to 29 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0407, Norway

Location

Related Publications (2)

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum.

MeSH Terms

Conditions

Coronary Artery DiseaseCardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Arnljot Flaa, MD PhD

    Oslo University Hospital

    STUDY CHAIR
  • Ingebjørg Seljeflot, Professor PhD

    Oslo University Hospital and University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 9, 2011

First Posted

December 19, 2011

Study Start

December 1, 2011

Primary Completion

October 1, 2017

Study Completion

March 1, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations