Back to resultsTroponin T in Chronic Obstructive Pulmonary Disease (COPD) Patients After Physical Exercise
Primary Purpose
COPD, Myocardial Diseases
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Treadmill exercise test
Sponsored by
About this trial
This is an interventional diagnostic trial for COPD focused on measuring Troponin, Exercise
Eligibility Criteria
Inclusion Criteria:
- COPD
- GOLD 2-4
- BODE-index ≥ 2
- Referred by physician to a CPET
Exclusion Criteria:
- Other serious pulmonary diseases (e.g. cancer, sarcoidosis, restrictive pulmonary diseases)
- Chronic heart disease with unstable angina or myocardial infarction ≤ 3 months prior to inclusion
- Percutaneous coronary intervention (PCI)
- Hypertension that is not controlled
Sites / Locations
- LHL-klinikkene
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treadmill exercise test
Arm Description
Patients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion
Outcomes
Primary Outcome Measures
Troponin T concentration 3 h
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02721693
Brief Title
Troponin T in Chronic Obstructive Pulmonary Disease (COPD) Patients After Physical Exercise
Official Title
COPD, Physical Exercise and Troponin T
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LHL Helse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of the study is to investigate if physical exercise is associated with myocardial damage, expressed by elevated troponin T, in patients with COPD.
Detailed Description
Patients with COPD will perform a cardiopulmonary exercise test (CPET) on treadmill until exhaustion, 8-12 minutes. Venous blood will be drawn before exercise test and 15 minutes, 3 hours and 24 hours after test for analysis of high sensitive Cardiac troponin T (hs-cTnT). The investigators will also measure arterial bloodgas, oxygen uptake, carbon dioxide consumption, ventilation, blood pressure, ECG, heart rate and ask for dyspnea-score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Myocardial Diseases
Keywords
Troponin, Exercise
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treadmill exercise test
Arm Type
Experimental
Arm Description
Patients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion
Intervention Type
Device
Intervention Name(s)
Treadmill exercise test
Intervention Description
Patients are subjected to an incremental exercise test to exhaustion on a treadmill
Primary Outcome Measure Information:
Title
Troponin T concentration 3 h
Time Frame
3 h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD
GOLD 2-4
BODE-index ≥ 2
Referred by physician to a CPET
Exclusion Criteria:
Other serious pulmonary diseases (e.g. cancer, sarcoidosis, restrictive pulmonary diseases)
Chronic heart disease with unstable angina or myocardial infarction ≤ 3 months prior to inclusion
Percutaneous coronary intervention (PCI)
Hypertension that is not controlled
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne H Edvardsen, PhD
Organizational Affiliation
LHL Helse
Official's Role
Principal Investigator
Facility Information:
Facility Name
LHL-klinikkene
City
Hakadal
State/Province
Akershus
ZIP/Postal Code
1485
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Troponin T in Chronic Obstructive Pulmonary Disease (COPD) Patients After Physical Exercise
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