Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT01290159
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2011-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Development Of A Novel Biomarker For Early Identification Of The Individual's State Of Tolerance To Heat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018883', 'term': 'Heat Stroke'}], 'ancestors': [{'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2011-02-03', 'studyFirstSubmitQcDate': '2011-02-03', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tolerance to heat'], 'conditions': ['Heat Stroke', 'Healthy']}, 'descriptionModule': {'briefSummary': "Today, the level of tolerance to heat is based on physiological strain indices, with no correlates to any relevant biomarker. We hypothesize that oxidative stress (OS) and the formation of reactive oxygen and nitrogen species (ROS, RNS), which are part of the underling pathophysiology related to hyperthermia, can be used to identify tolerance/intolerance to heat. The aim of the present project is to develop a simple assay, based on specific designed sensitive biomarkers of OS that can be detected in a small blood sample, and to possibly correlate each individual's state of tolerance to heat to the level of OS. These biomarkers specially designed and synthesized to form a novel probe (not present as such in biological organs). The method will be based on the incubation of the suggested biomarkers with the patient's blood sample and the measurement of the level and type of oxidative alteration of the markers. For this goal, post heat stroke patients, with different levels of tolerance to heat and subjects during a process of acclimation to heat will be studied. Such a method will add to our ability to better determine the level of tolerance to heat and not rely only on the measurements of temperature and heart rate during an exercise-heat stress."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'young (18-28 years old) post heat stroke subjects, and matched healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nfor study group: post heat stroke subjects. for control group: healthy subjects matched by age to study group\n\nExclusion Criteria:\n\nfor control group: any prior heat illness, Diabetes, heart failure, high blood pressure (SBP \\>140mmHg), any febrile illness within the last two weeks prior to testing.\n\nfor study group: Diabetes, heart failure, high blood pressure (SBP \\>140mmHg), any febrile illness within the last two weeks prior to testing'}, 'identificationModule': {'nctId': 'NCT01290159', 'briefTitle': "The Development Of A Novel Biomarker For Early Identification Of The Individual's State Of Tolerance To Heat", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Preliminary Study of Identifying the Tolerance to Heat by a Novel Biomarker of Oxidative Stress', 'orgStudyIdInfo': {'id': 'SHEBA-10-8150-CM-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'post heat stroke heat tolerant', 'interventionNames': ['Other: heat tolerance test (HTT)']}, {'label': 'post heat stroke heat intolerant', 'interventionNames': ['Other: heat tolerance test (HTT)']}, {'label': 'healthy controls', 'interventionNames': ['Other: heat tolerance test (HTT)']}], 'interventions': [{'name': 'heat tolerance test (HTT)', 'type': 'OTHER', 'otherNames': ['heat strain'], 'description': 'An exercise-heat test,which consists of 120 min exposure to walking on a treadmill (5km/h; 2% grade) under conditions of 40oC and 50% rh.', 'armGroupLabels': ['healthy controls', 'post heat stroke heat intolerant', 'post heat stroke heat tolerant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Heller Institute of Medical Research, Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'overallOfficials': [{'name': 'Yoram Epstein, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Heller Institute of Medical Research, Sheba Medical Center, Tel Hashomer'}, {'name': 'Amit Druyan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heller Institute of Medical Research, Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Heller institue, Sheba Medical Center', 'investigatorFullName': 'Prof. Yoram Epstein', 'investigatorAffiliation': 'Sheba Medical Center'}}}}