Cardiovascular Patient Outcomes and Research Team Primary PCI Registry (CPORT)

Johns Hopkins University

Status: Completed

Conditions: ST Elevation Myocardial Infarction

Study type: Observational

Funder types: Other

Identifiers

NCT02201264

11.2

Details and patient eligibility

About

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.

Full 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

Enrollment: 6,726 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. age > 18 years

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

1. inability to obtain informed consent (surrogate consent may be obtained if approved by your IRB)

Trial design

6,726 participants in 1 patient group

Primary PCI for STEMI patients

Description:

Primary PCI for patients presenting with ST elevation MIs