Coronary Artery DiseaseCPORTNCT02137980
Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site
An observational study of Coronary Artery Disease and Heart Attack, run by Johns Hopkins University at 37 sites in United States.
Trial summary
This is a simple registry of patients undergoing PCI at hospitals without surgery on-site who were participants in the CPORT-E project. The aim of the registry is simple data collection and reporting to respective State Departments of Health. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Coronary Artery Disease, Heart Attack, Angina
- How many people
- 31,390 participants
- Where
- 37 sitesUnited States
- Study dates
- 1 Apr 2011to Mar 2016
- How long will I take part?
- 1 Week
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population includes inpatients and outpatients undergoing diagnostic cardiac catheterization for suspected coronary artery disease (CAD) at hospitals without SOS.
Who may be able to join
- Patient inclusion criteria are:
- Pre-catheterization
- must be undergoing diagnostic cardiac catheterization for suspected CAD
- be at least 18 years of age
- must not be pregnant (negative pregnancy test) or must not be of childbearing potential
- must be able to give informed consent. Post-catheterization
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- coronary artery disease judged to be clinically and angiographically significant
- ability to perform PCI with equipment available at the local site (see below)
- procedure risk judged to be not high (see below)
Who cannot join
- Patient exclusion criteria are:
- Pre-catheterization
- inability to give informed consent
- ST-segment elevation myocardial infarction
- pregnancy Post-catheterization
- high likelihood of requiring a device not available at the hospitals without SOS (see below)
Show all 9Show fewer
- no need for PCI
- need for coronary artery bypass surgery
- high procedural risk (see below)
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Hopkins Bayview Medical Center
Baltimore, Maryland, 21044
Bayonne Medical Center
Bayonne, New Jersey, 07002
Clara Maas Medical Center
Belleville, New Jersey, 07109
Community Health and Wellness Center
Bryan, Ohio, 43506
St. Agnes Hospital
Catonsville, Maryland, 21229
University Hospital Geauga Medical Center
Chardon, Ohio, 44024
Southern Maryland Hospital Center
Clinton, Maryland, 20735
Ohio State University Hospital East
Columbus, Ohio, 43205
Mt. Carmel St. Ann Hospital
Columbus, Ohio, 43213
Southview Medical Center
Dayton, Ohio, 45459
JFK Medical Center
Edison, New Jersey, 08818
Trinitas Hospital
Elizabeth, New Jersey, 07207
Frederick Memorial Hospital
Frederick, Maryland, 21701
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
Meritus Medical Center
Hagerstown, Maryland, 21742
Fort Hamilton Hospital
Hamilton, Ohio, 45013
Crestwood Medical Center
Huntsville, Alabama, 35801
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
Evangelical Community Hospital
Lewisburg, Pennsylvania, 17837
Marietta Memorial Hospital
Marietta, Ohio, 45750
Virtua West Jersey Hospital
Marlton, New Jersey, 08053
UPMC McKeesport
McKeesport, Pennsylvania, 15132
Meadville Medical Center
Meadville, Pennsylvania, 16335
Monongahela Valley Hospital
Monongahela, Pennsylvania, 15063
Knox Community Hospital
Mount Vernon, Ohio, 43050
Licking Memorial Hospital
Newark, Ohio, 43055
Raritan Bay Medical Center
Perth Amboy, New Jersey, 08861
Nazareth Hospital
Philadelphia, Pennsylvania, 19152
Riverview Medical Center
Red Bank, New Jersey, 07701
Shady Grove Adventist Hospital
Rockville, Maryland, 20850
Somerset Medical Center
Somerville, New Jersey, 08876
Overlook Hospital
Summit, New Jersey, 07901
Holy Name Hospital
Teaneck, New Jersey, 07666
Community Medical Center
Toms River, New Jersey, 08755
West Chester Hospital
West Chester, Ohio, 45069
Memorial Hospital
York, Pennsylvania, 17403
About this study
This is a simple registry of patients undergoing PCI at hospitals without surgery on-site who were participants in the CPORT-E project. The aim of the registry is simple data collection and reporting to respective State Departments of Health. The registry population consists of patients undergoing diagnostic cardiac catheterization for suspected CAD at hospitals without SOS and who require PCI.
- Conditions
- Coronary Artery Disease, Heart Attack, Angina
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Thru Index or Transfer Hospital Discharge on average 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study start1 Apr 2011
- Primary completion31 Dec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 31,390 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Aversano, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137980
- Sponsor's protocol ID
- NA_00046362
- Acronym
- CPORT
- Status last verified
- Apr 2018
- First submitted
- 18 Mar 2014
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site
- ClinicalTrials.gov ID
- NCT02137980
- Acronym / sponsor ID
- CPORT / NA_00046362
- Conditions
- Coronary Artery Disease, Heart Attack, Angina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31,390 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 May 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.
This is a simple registry of patients undergoing PCI at hospitals without surgery on-site who were participants in the CPORT-E project. The aim of the registry is simple data collection and reporting to respective State Departments of Health. The registry population consists of patients undergoing diagnostic cardiac catheterization for suspected CAD at hospitals without SOS and who require PCI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population includes inpatients and outpatients undergoing diagnostic cardiac catheterization for suspected coronary artery disease (CAD) at hospitals without SOS.
Key inclusion criteria (9 listed)
- Pre-catheterization
- must be undergoing diagnostic cardiac catheterization for suspected CAD
- be at least 18 years of age
- must not be pregnant (negative pregnancy test) or must not be of childbearing potential
- must be able to give informed consent. Post-catheterization
Key exclusion criteria (9 listed)
- Pre-catheterization
- inability to give informed consent
- ST-segment elevation myocardial infarction
- pregnancy Post-catheterization
- high likelihood of requiring a device not available at the hospitals without SOS (see below)
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
Number of participants with adverse events
Time frame: Thru Index or Transfer Hospital Discharge on average 24 hours
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 12 Apr 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 principal investigator
Johns Hopkins University
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Heart Attack, run by Johns Hopkins University at 37 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 9 inclusion and 9 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 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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?
Number of participants with adverse events (time frame: Thru Index or Transfer Hospital Discharge on average 24 hours). 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 12 Apr 2018.