Cardiovascular Patient Outcomes and Research Team Primary PCI Registry
NCT ID: NCT02201264
Last Updated: 2018-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6726 participants
OBSERVATIONAL
2006-04-30
2015-12-31
Brief Summary
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The aim of this registry is to define the outcomes of patients treated for acute, ST-segment myocardial infarction (STEMI) at community hospitals without on-site cardiac surgery programs that have completed the Cardiovascular Patient Outcomes and Research Team (C-PORT) Primary Angioplasty Development program. The primary medical outcome for the registry is the combined incidence of death, recurrent non-fatal myocardial infarction and stroke.
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Detailed Description
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Secondary endpoints include:
1. composite of death, recurrent non-fatal MI and stroke at hospital discharge and at 6 months
2. specific subgroup analyses are planned based on history of diabetes age anterior versus other infarct locations race gender
3. incidence of complications including significant bleeding, need for coronary artery bypass surgery, cardiac arrest
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Primary PCI for STEMI patients
Primary PCI for patients presenting with ST elevation MIs
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. ability to give informed consent
3. acute myocardial infarction with
1. \> 30 mins ongoing ischemic cardiac pain at presentation and \> 0.1 mv ST-segment elevation in 2 or more contiguous ECG leads or
2. new or suspected new Left Bundle Branch Block (LBBB) or
3. \> 0.1 mv ST-segment depression in V1 and V2 consistent with true posterior infarction
4. rescue PCI for failed thrombolytics
5. cardiogenic shock - (defined as systolic blood pressure \<80 mmHg sustained for more than 30 minutes despite correction of non-myocardial factors (hypovolemia, acidosis, arrhythmia, etc) or requirement for pressors and/or intra-aortic balloon pump (IABP) to sustain systolic blood pressure \> 80 mmHg)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Thomas Aversano, MD
Role: STUDY_DIRECTOR
Johns Hopkins School of Medicine
Locations
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Community Health and Wellness Center
Bryan, Ohio, United States
University Hospital Geauga Medical Center
Chardon, Ohio, United States
Ohio State University East
Columbus, Ohio, United States
Southview Medical Center
Dayton, Ohio, United States
Fort Hamilton Hospital
Hamilton, Ohio, United States
Marietta Memorial
Marietta, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Westchester Hospital
Westchester, Ohio, United States
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States
UPMC McKeesport
McKeesport, Pennsylvania, United States
Meadville Medical Center
Meadville, Pennsylvania, United States
Nazareth Hospital
Philadelphia, Pennsylvania, United States
Memorial Hospital
York, Pennsylvania, United States
Countries
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Other Identifiers
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11.2
Identifier Type: -
Identifier Source: org_study_id
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