NCT02721693

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

March 23, 2016

Last Update Submit

October 10, 2016

Conditions

COPDMyocardial Diseases

Keywords

TroponinExercise

Outcome Measures

Primary Outcomes (1)

  • Troponin T concentration 3 h

    3 h

Study Arms (1)

Treadmill exercise test

EXPERIMENTAL

Patients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion

Device: Treadmill exercise test

Interventions

Treadmill exercise testDEVICE

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

Treadmill exercise test

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD
  • GOLD 2-4
  • BODE-index ≥ 2
  • Referred by physician to a CPET

You may not qualify if:

  • Other serious pulmonary diseases (e.g. cancer, sarcoidosis, restrictive pulmonary diseases)
  • Percutaneous coronary intervention (PCI)
  • Hypertension that is not controlled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHL-klinikkene

Hakadal, Akershus, 1485, Norway

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCardiomyopathiesMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Anne H Edvardsen, PhD

    LHL Helse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Out Patient and Laboratory Department, Researcher

Study Record Dates

First Submitted

March 23, 2016

First Posted

March 29, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 11, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)