Cardiovascular Patient Outcomes and Research Team Primary PCI Registry

The Atlantic CPORT Primary PCI Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02201264

Acronym

CPORT

Enrollment

6726

Registered

2014-07-28

Start date

2006-04-30

Completion date

2015-12-31

Last updated

2018-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST Elevation Myocardial Infarction

Keywords

myocardial infarction, Angioplasty, Stent

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results