Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-02 @ 4:24 PM
Study NCT ID:
NCT06635603
Status:
RECRUITING
Last Update Posted:
2024-10-10
First Post:
2024-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HYPERTENSIVE CRISIS AND ATMOSPHERIC PRESSURE RELATIONSHIP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096003', 'term': 'Hypertensive Crisis'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-10-08', 'studyFirstSubmitQcDate': '2024-10-08', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypertensive Crisis', 'timeFrame': 'from enrollment to the end of follow up duration of 7 days', 'description': "Patients' blood pressure values evaluation in terms of atmospheric pressure and weather conditions"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atmospheric pressure', 'hypertension', 'hypertensive urgency'], 'conditions': ['Hypertensive Urgency', 'Weather']}, 'referencesModule': {'references': [{'pmid': '31415308', 'type': 'RESULT', 'citation': 'Salvetti M, Paini A, Colonetti E, Tarozzi L, Bertacchini F, Aggiusti C, Stassaldi D, Rosei CA, Rosei EA, Muiesan ML. Hypertensive emergencies and urgencies: a single-centre experience in Northern Italy 2008-2015. J Hypertens. 2020 Jan;38(1):52-58. doi: 10.1097/HJH.0000000000002213.'}, {'pmid': '12441212', 'type': 'RESULT', 'citation': 'Jehn M, Appel LJ, Sacks FM, Miller ER 3rd; DASH Collaborative Research Group. The effect of ambient temperature and barometric pressure on ambulatory blood pressure variability. Am J Hypertens. 2002 Nov;15(11):941-5. doi: 10.1016/s0895-7061(02)02999-0.'}, {'pmid': '23381792', 'type': 'RESULT', 'citation': 'Modesti PA, Morabito M, Massetti L, Rapi S, Orlandini S, Mancia G, Gensini GF, Parati G. Seasonal blood pressure changes: an independent relationship with temperature and daylight hours. Hypertension. 2013 Apr;61(4):908-14. doi: 10.1161/HYPERTENSIONAHA.111.00315. Epub 2013 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'relationship between the onset times of symptoms and the regions of patients presenting to the emergency department with hypertensive crisis (systolic ≥180 and/or diastolic ≥110 mmHg) and the fluctuations in atmospheric pressure', 'detailedDescription': 'Hypertensive emergency is defined as grade 3 hypertension (systolic ≥180 and/or diastolic ≥110 mmHg) that causes end-organ damage, requiring urgent intervention and intensive care admission . Hypertensive crisis is described as severe hypertension not associated with end-organ damage. Some sources define hypertensive crisis as hypertension of grade 3 or higher, while others refer to it as severe hypertension without specifying a threshold .\n\nLiterature reviews, published guidelines, and studies indicate that the definitions and treatment approaches for hypertensive crisis differ between Europe and America, with variations in management from one physician to another . Seasonal blood pressure fluctuations are influenced by external temperature, indoor temperature, humidity, atmospheric pressure, and wind . Notably, during periods of low atmospheric pressure, blood pressure measurements show statistically significant increases compared to other days . Consequently, the frequency of life-threatening conditions associated with hypertension, such as intracranial hemorrhage and abdominal aortic aneurysm rupture, has been observed to increase on days when atmospheric pressure changes .\n\nIn our study, we aim to investigate the relationship between the onset times of symptoms and the regions of patients presenting to the emergency department with hypertensive crisis (systolic ≥180 and/or diastolic ≥110 mmHg) and the fluctuations in atmospheric pressure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to emergency department with hypertensive urgency ( systolic ≥180 and/or diastolic ≥110 mmHg )', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 and above\n2. Hypertensive crisis (systolic ≥180 and/or diastolic ≥110 mmHg)\n\nExclusion Criteria:\n\n1. Patients presenting with hypertensive emergency (those with end-organ damage)\n2. Patients who have traveled to another city or district within the last 4 days\n3. Pregnant patients'}, 'identificationModule': {'nctId': 'NCT06635603', 'briefTitle': 'HYPERTENSIVE CRISIS AND ATMOSPHERIC PRESSURE RELATIONSHIP', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'HYPERTENSIVE CRISIS AND ATMOSPHERIC PRESSURE RELATIONSHIP: A PROSPECTIVE STUDY', 'orgStudyIdInfo': {'id': 'Hypertension, ATM pressure'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hypertension', 'description': 'patients admitted to emergency department with grade 3 (systolic ≥180 and/or diastolic ≥110 mmHg) blood pressure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gulsen AKCAY, Associate Professor', 'role': 'CONTACT', 'email': 'gulakcay@yahoo.com.tr', 'phone': '+905052874949'}, {'name': 'Elif HAMZACEBIOGLU KAYISOGLU, Specialist', 'role': 'CONTACT', 'email': 'turkuaz-61@windowslive.com', 'phone': '+905453300679'}, {'name': 'Gulsen AKCAY, Ass. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Elif HAMZACEBIOGLU KAYISOGLU, Specialist', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Murat Ozdemir, Specialist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fatma BUYUKCELEN CIFTCI, resident', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fatma Nur KOC, Resident', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bedriye Muge SONMEZ, ass. prof.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Gulsen AKCAY, Ass. Prof.', 'role': 'CONTACT', 'email': 'gulakcay@yahoo.com.tr', 'phone': '+905052874949'}, {'name': 'Elif HAMZACEBIOGLU KAYISOGLU, Specialist', 'role': 'CONTACT', 'email': 'turkuaz-61@indowslive.com', 'phone': '+905453300679'}], 'overallOfficials': [{'name': 'Gulsen AKCAY, ass. prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara Etlik City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Etimesgut Military Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}