Cardiovascular Patient Outcomes and Research Team Primary PCI Registry
- Conditions
- ST Elevation Myocardial Infarction
- Registration Number
- NCT02201264
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
The proposed study is a registry of patients treated with primary angioplasty for acute myocardial infarction.
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.
- Detailed Description
The primary study endpoint is the composite incidence of death, non-fatal reinfarction and stroke 6 weeks after index myocardial infarction.
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6726
-
age > 18 years
-
ability to give informed consent
-
acute myocardial infarction with
- > 30 mins ongoing ischemic cardiac pain at presentation and > 0.1 mv ST-segment elevation in 2 or more contiguous ECG leads or
- new or suspected new Left Bundle Branch Block (LBBB) or
- > 0.1 mv ST-segment depression in V1 and V2 consistent with true posterior infarction
-
rescue PCI for failed thrombolytics
-
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
- inability to obtain informed consent (surrogate consent may be obtained if approved by your IRB)
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite incidence of death, non-fatal reinfarction and stroke. 6 weeks after myocardial infarction The primary study endpoint is the composite incidence of death, non-fatal reinfarction and stroke 6 weeks after index myocardial infarction.
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Nazareth Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Memorial Hospital
🇺🇸York, Pennsylvania, United States
Ohio State University East
🇺🇸Columbus, Ohio, United States
Community Health and Wellness Center
🇺🇸Bryan, Ohio, United States
University Hospital Geauga Medical Center
🇺🇸Chardon, Ohio, United States
Fort Hamilton Hospital
🇺🇸Hamilton, Ohio, United States
Southview Medical Center
🇺🇸Dayton, Ohio, United States
Marietta Memorial
🇺🇸Marietta, Ohio, United States
Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Knox Community Hospital
🇺🇸Mount Vernon, 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