Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT07018193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Study of Personalized Health Check-up Programs and Standards for High-altitude Migrant Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of high altitude sickness and related diseases.', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Early diagnosis rates of acute and chronic altitude sickness and related diseases induced or aggravated by the plateau population in migrant plateau populations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Altitude']}, 'descriptionModule': {'briefSummary': 'By using wearable devices to monitor and record the physiological data changes and health outcomes (incidence and severity of high-altitude illnesses) of high-altitude migrants at different stages (pre-entry, acute/chronic high-altitude phases, and de-acclimatization phase), and referencing previous cohort studies on high-altitude populations, the study aims to provide a basis for developing personalized health assessment protocols for high-altitude migrants. The formulated assessment protocols and standards will then be validated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Recruit those who live in plains and prepare to move to the plateau in the short term or medium term.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged ≥18;\n* Those living in plains and preparing to move to the plateau for a short-term or medium-term period;\n* Can understand the research requirements and be willing to sign a written informed consent form (ICF).\n\nExclusion Criteria:\n\n* Past history of contraindicated plateau travel: such as advanced COPD (FEV₁\\<30% of the expected value or requires continuous oxygen therapy), advanced cystic fibrosis (FEV₁\\<30% of the expected value or requires continuous oxygen therapy), advanced restricted pulmonary disease (FEV₁\\<50% of the expected value or requires continuous oxygen therapy), decompensated heart failure, high-risk pregnancy, myocardial infarction or stroke occurred within 90 days, poorly controlled epilepsy, pulmonary hypertension (PASP\\>90mmHg), sickle cell anemia, unstable angina pectoris, high-risk cerebrovascular abnormalities that have not been treated, etc.'}, 'identificationModule': {'nctId': 'NCT07018193', 'briefTitle': 'The Study of Personalized Health Check-up Programs and Standards for High-altitude Migrant Populations', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'The Study of Personalized Health Check-up Programs and Standards for High-altitude Migrant Populations', 'orgStudyIdInfo': {'id': 'PHC-high'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exploration group', 'description': '200 participants, to explore and formulate and optimize personalized plans and standards for health examinations for people living in plateaus.'}, {'label': 'Verification group', 'description': '100 participants, to verify the feasibility of the physical examination plan and its effectiveness in the early diagnosis of altitude sickness and plateau environment-related comorbidities.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yuan Wang, MD', 'role': 'CONTACT', 'email': 'wilma0106@163.com', 'phone': '+86-13581567815'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ji Xunming,MD,PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}