Troponin T in Chronic Obstructive Pulmonary Disease (COPD) Patients After Physical Exercise

October 10, 2016 updated by: Anne Helene Edvardsen, LHL Helse

COPD, Physical Exercise and Troponin T

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Hakadal, Akershus, Norway, 1485
        • LHL-Klinikkene

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treadmill exercise test
Patients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion
Device: Treadmill exercise test
Patients are subjected to an incremental exercise test to exhaustion on a treadmill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Troponin T concentration 3 h
Time Frame: 3 h
3 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LHL Helse

Investigators

  • Principal Investigator: Anne H Edvardsen, PhD, LHL Helse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (Estimate)

March 29, 2016

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/23140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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