Clinical trial NCT02201264: Cardiovascular Patient Outcomes and Research Team Primary PCI Registry
Official title: The Atlantic CPORT Primary PCI Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST Elevation Myocardial Infarction
Keywords: myocardial infarction
Angioplasty
Stent
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 6726
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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)

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.

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

Eligibility 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)

Primary outcomes:
measure: Composite incidence of death, non-fatal reinfarction and stroke.
timeFrame: 6 weeks after myocardial infarction
Secondary outcomes:
Other outcomes:
Locations:
city: Bryan
country: United States
facility: Community Health and Wellness Center
state: Ohio
city: Chardon
country: United States
facility: University Hospital Geauga Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University East
state: Ohio
city: Dayton
country: United States
facility: Southview Medical Center
state: Ohio
city: Hamilton
country: United States
facility: Fort Hamilton Hospital
state: Ohio
city: Marietta
country: United States
facility: Marietta Memorial
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Hospital
state: Ohio
city: Westchester
country: United States
facility: Westchester Hospital
state: Ohio
city: Kittanning
country: United States
facility: Armstrong County Memorial Hospital
state: Pennsylvania
city: McKeesport
country: United States
facility: UPMC McKeesport
state: Pennsylvania
city: Meadville
country: United States
facility: Meadville Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Nazareth Hospital
state: Pennsylvania
city: York
country: United States
facility: Memorial Hospital
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Thomas Aversano, MD
role: STUDY_DIRECTOR
References: