Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-17 @ 9:30 PM
Study NCT ID:
NCT03444857
Status:
UNKNOWN
Last Update Posted:
2018-02-23
First Post:
2018-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2018-02-20', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial salvage index', 'timeFrame': '3 months', 'description': 'To investigate the effects of CPAP treatment on myocardial salvage index (MSI, assessed by cardiovascular magnetic resonance imaging, CMR) at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Continuous Positive Airway Pressure', 'Myocardial Salvage', 'Obstructive Sleep Apnea', 'ST Elevation Myocardial Infarction'], 'conditions': ['Obstructive Sleep Apnea', 'ST Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled trial to investigate the effects of CPAP treatment on myocardial salvage index and clinical outcomes at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 to 80 years old\n2. First-time STEMI\n3. Successful PPCI (≥1 coronary artery) within 24h after symptom onset\n4. Moderate to severe OSA (AHI≥15)\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Prior myocardial infarction\n2. Prior myocardial revascularization (PCI or CABG)\n3. Cardiogenic shock (mean arterial pressure \\<60mmHg), severe heart failure (Killip≥3)\n4. LM or multivessel disease indicated for CABG\n5. History of stroke\n6. Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep \\<4h/night)\n7. Severe COPD: FEV1/FVC \\<70% or FEV1 \\<50% predicted value (within 4 weeks)\n8. Predominantly central sleep apnea (≥25% central events or central AHI ≥10/h)\n9. Previous or current use of CPAP\n10. Severe comorbidities: eg. malignancy (life expectancy \\<2 years)\n11. Known or planned pregnancy\n12. Known contraindication to CMR\n13. Patients with contraindication to CPAP or who cannot tolerate it\n14. Participation in other clinical trial in recent 3 months\n15. Any condition that in the opinion of investigator that may jeopardize patient compliance, eg. significant memory, perceptual, or behavioral disorder, depression, severe alcohol consumption, or a history of noncompliance'}, 'identificationModule': {'nctId': 'NCT03444857', 'briefTitle': 'CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Effect of Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea (OSA) on Myocardial Salvage After Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2018006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP treatment', 'description': 'Continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) plus standard care (according to current STEMI guidelines) for 3 months after pPCI', 'interventionNames': ['Device: Continuous positive airway pressure']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard care (according to current STEMI guidelines) for 3 months after PPCI with no intervention for OSA'}], 'interventions': [{'name': 'Continuous positive airway pressure', 'type': 'DEVICE', 'otherNames': ['CPAP'], 'description': 'The optimal continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) settings will be determined during 1-2 nights within 7 days after pPCI.', 'armGroupLabels': ['CPAP treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Fu-Sui JI, MD', 'role': 'CONTACT'}], 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shao-Ping NIE, MD', 'role': 'CONTACT', 'email': 'spnie@126.com', 'phone': '86 13701186772'}], 'overallOfficials': [{'name': 'Shao-Ping NIE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Emergency & Critical Care Center, Professor of Medicine', 'investigatorFullName': 'Shao-Ping Nie', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}