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

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

Study Description

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

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

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

More Information

Additional Information:

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02201264
• Other Study ID Numbers: 11.2
• First Posted: July 28, 2014
• Last Update Posted: October 4, 2018
• Last Verified: October 2018

Keywords provided by Johns Hopkins University:

myocardial infarction; Angioplasty; Stent

Additional relevant MeSH terms:

Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases