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OpenTrials
Completed

NCT Number: NCT02201264

Cardiovascular Patient Outcomes and Research Team 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Community Health and Wellness Center, Bryan, Ohio, United States

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About this study

The primary study endpoint is the composite incidence of death, non-fatal reinfarction and stroke 6 weeks after index myocardial infarction.

Secondary endpoints include:

  • composite of death, recurrent non-fatal MI and stroke at hospital discharge and at 6 months
  • specific subgroup analyses are planned based on history of diabetes age anterior versus other infarct locations race gender
  • incidence of complications including significant bleeding, need for coronary artery bypass surgery, cardiac arrest

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. 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:

    • composite of death, recurrent non-fatal MI and stroke at hospital discharge and at 6 months
    • specific subgroup analyses are planned based on history of diabetes age anterior versus other infarct locations race gender
    • incidence of complications including significant bleeding, need for coronary artery bypass surgery, cardiac arrest

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

The Atlantic CPORT Primary PCI Registry

Acronym: CPORT

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Jul 28, 2014
Registry last updated
Oct 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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