Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT02721693
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2016-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Troponin T in Chronic Obstructive Pulmonary Disease (COPD) Patients After Physical Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2016-03-23', 'studyFirstSubmitQcDate': '2016-03-28', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Troponin T concentration 3 h', 'timeFrame': '3 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Troponin', 'Exercise'], 'conditions': ['COPD', 'Myocardial Diseases']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD\n* GOLD 2-4\n* BODE-index ≥ 2\n* Referred by physician to a CPET\n\nExclusion Criteria:\n\n* Other serious pulmonary diseases (e.g. cancer, sarcoidosis, restrictive pulmonary diseases)\n* Chronic heart disease with unstable angina or myocardial infarction ≤ 3 months prior to inclusion\n* Percutaneous coronary intervention (PCI)\n* Hypertension that is not controlled'}, 'identificationModule': {'nctId': 'NCT02721693', 'briefTitle': 'Troponin T in Chronic Obstructive Pulmonary Disease (COPD) Patients After Physical Exercise', 'organization': {'class': 'OTHER', 'fullName': 'LHL Helse'}, 'officialTitle': 'COPD, Physical Exercise and Troponin T', 'orgStudyIdInfo': {'id': '2016/23140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treadmill exercise test', 'description': 'Patients are subjected to an incremental Cardiopulmonary Exercise Test to exhaustion', 'interventionNames': ['Device: Treadmill exercise test']}], 'interventions': [{'name': 'Treadmill exercise test', 'type': 'DEVICE', 'description': 'Patients are subjected to an incremental exercise test to exhaustion on a treadmill', 'armGroupLabels': ['Treadmill exercise test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1485', 'city': 'Hakadal', 'state': 'Akershus', 'country': 'Norway', 'facility': 'LHL-klinikkene', 'geoPoint': {'lat': 60.12146, 'lon': 10.82399}}], 'overallOfficials': [{'name': 'Anne H Edvardsen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LHL Helse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LHL Helse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Out Patient and Laboratory Department, Researcher', 'investigatorFullName': 'Anne Helene Edvardsen', 'investigatorAffiliation': 'LHL Helse'}}}}