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

October 2, 2018 updated by: Johns Hopkins University

The Atlantic CPORT Primary PCI Registry

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

6726

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Bryan, Ohio, United States, 43506
        • Community Health and Wellness Center
      • Chardon, Ohio, United States, 44024
        • University Hospital Geauga Medical Center
      • Columbus, Ohio, United States, 43205
        • Ohio State University East
      • Dayton, Ohio, United States, 45459
        • Southview Medical Center
      • Hamilton, Ohio, United States, 45013
        • Fort Hamilton Hospital
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Westchester, Ohio, United States, 45069
        • Westchester Hospital
    • Pennsylvania
      • Kittanning, Pennsylvania, United States, 16201
        • Armstrong County Memorial Hospital
      • McKeesport, Pennsylvania, United States, 15132
        • UPMC McKeesport
      • Meadville, Pennsylvania, United States, 16335
        • Meadville Medical Center
      • Philadelphia, Pennsylvania, United States, 19152
        • Nazareth Hospital
      • York, Pennsylvania, United States, 17403
        • Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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 LBBB or
  3. > 0.1 mv ST-segment depression in V1 and V2 consistent with true posterior infarction 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 IABP to sustain systolic blood pressure > 80 mmHg)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Primary PCI for STEMI patients
Primary PCI for patients presenting with ST elevation MIs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite incidence of death, non-fatal reinfarction and stroke.
Time Frame: 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
6 weeks after myocardial infarction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Study Director: Thomas Aversano, MD, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2006

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 24, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 28, 2014

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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