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

NCT ID: NCT02721693

Last Updated: 2016-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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COPD Myocardial Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Treadmill exercise test

Patients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion

Group Type EXPERIMENTAL

Treadmill exercise test

Intervention Type DEVICE

Patients are subjected to an incremental exercise test to exhaustion on a treadmill

Interventions

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Treadmill exercise test

Patients are subjected to an incremental exercise test to exhaustion on a treadmill

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LHL Helse

OTHER

Sponsor Role lead

Responsible Party

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Anne Helene Edvardsen

Head of Out Patient and Laboratory Department, Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne H Edvardsen, PhD

Role: PRINCIPAL_INVESTIGATOR

LHL Helse

Locations

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LHL-klinikkene

Hakadal, Akershus, Norway

Site Status

Countries

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Norway

Other Identifiers

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2016/23140

Identifier Type: -

Identifier Source: org_study_id

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