Cardiovascular Patient Outcomes and Research Team Primary PCI Registry

ST Elevation Myocardial Infarction Clinical Trial

— CPORT  

Official title:

The Atlantic CPORT Primary PCI Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201264
• Other study ID #: 11.2
• Status: Completed
• Start date: April 2006
• Est. completion date: December 2015

Study information

• Verified date: October 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6726
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Locations

Country	Name	City	State
United States	Community Health and Wellness Center	Bryan	Ohio
United States	University Hospital Geauga Medical Center	Chardon	Ohio
United States	Ohio State University East	Columbus	Ohio
United States	Southview Medical Center	Dayton	Ohio
United States	Fort Hamilton Hospital	Hamilton	Ohio
United States	Armstrong County Memorial Hospital	Kittanning	Pennsylvania
United States	Marietta Memorial	Marietta	Ohio
United States	UPMC McKeesport	McKeesport	Pennsylvania
United States	Meadville Medical Center	Meadville	Pennsylvania
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Licking Memorial Hospital	Newark	Ohio
United States	Nazareth Hospital	Philadelphia	Pennsylvania
United States	Westchester Hospital	Westchester	Ohio
United States	Memorial Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite incidence of death, non-fatal reinfarction and stroke.	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	6 weeks after myocardial infarction