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

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ClinicalTrials.gov Identifier: NCT02201264
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease
ST Elevation Myocardial Infarction

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 6726 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Days
Official Title: The Atlantic CPORT Primary PCI Registry
Actual Study Start Date : April 2006
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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



Primary Outcome Measures :
  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:

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201264


Locations
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United States, Ohio
Community Health and Wellness Center
Bryan, Ohio, United States, 43506
University Hospital Geauga Medical Center
Chardon, Ohio, United States, 44024
Ohio State University East
Columbus, Ohio, United States, 43205
Southview Medical Center
Dayton, Ohio, United States, 45459
Fort Hamilton Hospital
Hamilton, Ohio, United States, 45013
Marietta Memorial
Marietta, Ohio, United States, 45750
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Westchester Hospital
Westchester, Ohio, United States, 45069
United States, Pennsylvania
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States, 16201
UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
Meadville Medical Center
Meadville, Pennsylvania, United States, 16335
Nazareth Hospital
Philadelphia, Pennsylvania, United States, 19152
Memorial Hospital
York, Pennsylvania, United States, 17403
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Study Director: Thomas Aversano, MD Johns Hopkins School of Medicine
Additional Information:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02201264    
Other Study ID Numbers: 11.2
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Keywords provided by Johns Hopkins University:
myocardial infarction
Angioplasty
Stent
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases