Troponin T in Chronic Obstructive Pulmonary Disease (COPD... | NCT02721693

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

NCT02721693

Sponsor

LHL Helse

Status

Completed

Last Update Posted

Oct 11, 2016Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

COPD
Myocardial Diseases

Interventions

Treadmill exercise test

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Mar 23, 2016

First Submission Date that Met QC Criteria

Mar 28, 2016

First Posted Date

Mar 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anne Helene Edvardsen, Head of Out Patient and Laboratory Department, Researcher, LHL HelsePrincipal Investigator

Lead Sponsor

LHL HelseOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treadmill exercise test	Experimental	Patients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion	Device: Treadmill exercise test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treadmill exercise test	Device	Patients are subjected to an incremental exercise test to exhaustion on a treadmill	Treadmill exercise test

Measure	Description	Time Frame
Troponin T concentration 3 h		3 h

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne H Edvardsen, PhD	LHL Helse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LHL-klinikkene		Hakadal	Akershus	1485	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D009202	Cardiomyopathies
D009043	Motor Activity

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided