Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT01500902
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2011-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2011-11-22', 'studyFirstSubmitQcDate': '2011-12-28', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unstable Angina, Myocardial Infarction, Repeat Revascularization, Cardiac Death, Stroke', 'timeFrame': 'Will determine with statistical analysis after all patients have had 2 year follow-up'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '6 months post revascularization.', 'description': 'Quality of Life as assessed by SF12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Coronary Syndrome (ACS)', 'Percutaneous Intervention (PCI)', 'Coronary Stent (CStent)', 'Percutaneous Transluminal Coronary Angioplasty (PTCA)', 'stent placement', 'balloon angioplasty'], 'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if testing patients for endothelial dysfunction will help identify which patients are more likely at risk to have another heart attack in the future. Study participants will undergo mental stress testing while at the same time being connected to a device that measures endothelial function via the Endopat device. These same participants will also undergo a sleep study via the Watchpat device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing revascularization by percutaneous intervention (PCI) for Acute Coronary Syndrome (ACS) at Mayo (STEMI and NonSTEMI patients)\n2. Age greater than 18\n\nExclusion Criteria:\n\n1. Patients likely not to complete the study due to co-morbid conditions (end stage renal disease; liver failure; malignancies)\n2. Inability to sign a consent form or availability for follow up\n3. Patients unable to tolerate the blood pressure cuff inflation on both arms\n4. patients with tremors\n5. sustained non-sinus cardiac arrhythmias\n6. acrylic finger nails\n7. permanent pacemaker\n8. color blindness\n9. use of alpha blockers and short acting nitrates \\< 3 hours before study\n10. Federal Medical Center inmates'}, 'identificationModule': {'nctId': 'NCT01500902', 'briefTitle': 'Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': '09-000047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'vascular testing', 'description': 'We are assessing vascular testing in patients presenting with acute coronary syndrome to determine if this type of testing will help identify which patients are more likely at risk to have another heart attack.', 'interventionNames': ['Other: EndoPAT testing (non invasive device)', 'Other: WatchPAT testing (non-invasive device)']}], 'interventions': [{'name': 'EndoPAT testing (non invasive device)', 'type': 'OTHER', 'otherNames': ['Itamar EndoPAT 2000'], 'description': 'Using the EndoPAT device, we will assess endothelial function.', 'armGroupLabels': ['vascular testing']}, {'name': 'WatchPAT testing (non-invasive device)', 'type': 'OTHER', 'otherNames': ['Itamar WatchPAT 200'], 'description': 'Using the WATCHPAT device we will assess sleep apnea.', 'armGroupLabels': ['vascular testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Amir Lerman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qatar National Research Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Principal Investigator', 'investigatorFullName': 'Amir Lerman', 'investigatorAffiliation': 'Mayo Clinic'}}}}