Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT02076802
Status:
UNKNOWN
Last Update Posted:
2014-03-04
First Post:
2014-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regular Physical Exercise and Salt Diet on Coronary Artery Disease in Patients With Prehypertension(RESTRAIN Pre-HT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D058246', 'term': 'Prehypertension'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-28', 'studyFirstSubmitDate': '2014-02-25', 'studyFirstSubmitQcDate': '2014-02-28', 'lastUpdatePostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fatal and nonfatal myocardial infarction, or coronary revascularization', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prehypertension', 'coronary atherosclerosis', 'cardiovascular disease'], 'conditions': ['Coronary Atherosclerosis', 'Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'The epidemic data shows that prehypertension is associated with cardiovascular disease, and heavy dietary salt intake could improve the developing of hypertension. We detected the risk factors of coronary atherosclerosis of prehypertensive patients with different levels of salt intake.\n\nThe aim of this multicenter prospective, randomized controlled study is to evaluate regular physical exercise and salt diet effects on progression of coronary artery disease in patients with prehypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Coronary atherosclerosis patients with prehypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\naged 45-75 Admission systolic BP between 120 and 139mmHg or diastolic BP between 80 and 89mmHg coronary artery stenosis was 30%-70% -\n\nExclusion Criteria:\n\nwith a history of myocardial infarction, coronary revascularization, congenital heart disease and cerebrovascular diseases\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02076802', 'briefTitle': 'Regular Physical Exercise and Salt Diet on Coronary Artery Disease in Patients With Prehypertension(RESTRAIN Pre-HT)', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Regular Physical Exercise and Salt Diet Effect on Progression of Coronary Disease in Patients With Prehypertension', 'orgStudyIdInfo': {'id': 'GHSY-20130814'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'lifestyle counseling', 'description': 'physical exercises', 'interventionNames': ['Behavioral: physical exercises']}], 'interventions': [{'name': 'physical exercises', 'type': 'BEHAVIORAL', 'armGroupLabels': ['lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100016', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Han Yaling', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zhao Xin', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'General Hospital of Shenyang Militaly Region', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Han Yaling', 'role': 'CONTACT', 'email': 'hanyal@263.net', 'phone': '+86-24-23922184'}, {'name': 'Zhao Xin', 'role': 'CONTACT', 'email': '455759500@qq.com', 'phone': '+86-24-28897266'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'xin Zhao', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}