Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 6:09 PM
Study NCT ID:
NCT01660828
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
2012-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Test and Cardiac Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-08', 'studyFirstSubmitDate': '2012-07-23', 'studyFirstSubmitQcDate': '2012-08-08', 'lastUpdatePostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum level of high sensitive troponin at several timepoints', 'timeFrame': 'timepoints t= baseline, 0, 1, 2, 3,4 and 8 hours after finishing exercise', 'description': 'serum level of high sensitive troponin in response to intensive exercise test with or without RIPC at several timepoints'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exercise induced (high sensitive) troponin release', 'Ischemia reperfusion injury', 'Remote ischemic preconditioning'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'Strenuous exercise in apparent healthy individuals increases plasma (high sensitive) troponin levels. The underlying mechanism is not yet elucidated, but could be explained by changes due to a mismatch in oxygen demand and supply that mimic those of ischemia and reperfusion injury. If the mechanism underlying the troponin release during exercise is similar to that of ischemia reperfusion injury (IRI), than it should be susceptible to remote ischemic preconditioning (RIPC) as RIPC is a well validated technique to reduce IRI. To test this hypothesis healthy volunteers underwent a strenuous exercise test with or without preceding RIPC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18-45 year\n* willing to sign informed consent\n* healthy\n\nExclusion Criteria:\n\n* hypertension (systolic blood pressure \\>140 mmHg or diastolic blood pressure \\> 90 mmHg)\n* any cardiovascular abnormality in past medical history, physical examination or ECG, including QTc interval\n* drug abuse\n* alcohol abuse (\\> 3 units/day)\n* smoking during the last 2 years\n* BMI \\>30 kg/m2\n* inability to perform bicycle test\n* the presence of an absolute or relative contra-indication for exercise (table 2 in protocol)\n* the presence of diabetes (fasting glucose \\> 6.9 mmol/L, non-fasting glucose \\>11.0 mmol/L; if non-fasting glucose is \\> 6.9 mmol/L, blood glucose measurement will be repeated in fasting condition and should then not exceed 6.9 mmol/L)\n* total cholesterol in blood 6.6 mmol/L or higher'}, 'identificationModule': {'nctId': 'NCT01660828', 'briefTitle': 'Exercise Test and Cardiac Injury', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'The Effect of Remote Ischemic Preconditioning on Plasma Troponin I Appearance After a Standardized Cycling Test in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'EXTROP2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive cycling test preceded by RIPC', 'description': 'Intensive cycling test preceded by a RIPC protocol.', 'interventionNames': ['Other: remote ischemic preconditioning (RIPC)']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention/ RIPC', 'description': 'Intensive cycling test not preceded by a RIPC protocol.'}], 'interventions': [{'name': 'remote ischemic preconditioning (RIPC)', 'type': 'OTHER', 'description': 'RIPC protocol which consist of three 5-min cycles of bilateral forearm ischemia', 'armGroupLabels': ['Intensive cycling test preceded by RIPC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'G. Rongen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Nijmegen Medial Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}