Cardiovascular Patient Outcomes and Research Team Primary PCI Registry

NCT ID: NCT02201264

Last Updated: 2018-10-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

6726 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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

Conditions

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ST Elevation Myocardial Infarction

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University Hospital Geauga Medical Center

Chardon, Ohio, United States

Site Status

Ohio State University East

Columbus, Ohio, United States

Site Status

Southview Medical Center

Dayton, Ohio, United States

Site Status

Fort Hamilton Hospital

Hamilton, Ohio, United States

Site Status

Marietta Memorial

Marietta, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Hospital

Newark, Ohio, United States

Site Status

Westchester Hospital

Westchester, Ohio, United States

Site Status

Armstrong County Memorial Hospital

Kittanning, Pennsylvania, United States

Site Status

UPMC McKeesport

McKeesport, Pennsylvania, United States

Site Status

Meadville Medical Center

Meadville, Pennsylvania, United States

Site Status

Nazareth Hospital

Philadelphia, Pennsylvania, United States

Site Status

Memorial Hospital

York, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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11.2

Identifier Type: -

Identifier Source: org_study_id

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