ST Elevation Myocardial InfarctionCPORTNCT02201264
Cardiovascular Patient Outcomes and Research Team Primary PCI Registry
An observational study of ST Elevation Myocardial Infarction, run by Johns Hopkins University at 14 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- How many people
- 6,726 participants
- Where
- 14 sitesUnited States
- Study dates
- Apr 2006to Dec 2015
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- 1. inability to obtain informed consent (surrogate consent may be obtained if approved by your IRB)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Community Health and Wellness Center
Bryan, Ohio, 43506
University Hospital Geauga Medical Center
Chardon, Ohio, 44024
Ohio State University East
Columbus, Ohio, 43205
Southview Medical Center
Dayton, Ohio, 45459
Fort Hamilton Hospital
Hamilton, Ohio, 45013
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
Marietta Memorial
Marietta, Ohio, 45750
UPMC McKeesport
McKeesport, Pennsylvania, 15132
Meadville Medical Center
Meadville, Pennsylvania, 16335
Knox Community Hospital
Mount Vernon, Ohio, 43050
Licking Memorial Hospital
Newark, Ohio, 43055
Nazareth Hospital
Philadelphia, Pennsylvania, 19152
Westchester Hospital
Westchester, Ohio, 45069
Memorial Hospital
York, Pennsylvania, 17403
About this study
Official title: The Atlantic CPORT 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.
Read the 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:
- 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
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- myocardial infarction, Angioplasty, Stent
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary PCI for STEMI patients | Primary PCI for patients presenting with ST elevation MIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks after myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startApr 2006
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6,726 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Aversano, MD, Study director, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201264
- Sponsor's protocol ID
- 11.2
- Acronym
- CPORT
- Status last verified
- Oct 2018
- First submitted
- 24 Jul 2014
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Atlantic CPORT Primary PCI Registry
- ClinicalTrials.gov ID
- NCT02201264
- Acronym / sponsor ID
- CPORT / 11.2
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- myocardial infarction, Angioplasty, Stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,726 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2006 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary PCI for STEMI patients | – | –Primary PCI for patients presenting with ST elevation MIs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (8 listed)
- age > 18 years
- ability to give informed consent
- acute myocardial infarction with
- 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)
Key exclusion criteria (1 listed)
- 1. inability to obtain informed consent (surrogate consent may be obtained if approved by your IRB)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Aversano, MD study director
Johns Hopkins School of Medicine
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction, run by Johns Hopkins University at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of death, non-fatal reinfarction and stroke. (time frame: 6 weeks after myocardial infarction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.