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Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site (CPORT)

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ClinicalTrials.gov Identifier: NCT02137980
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief 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. The registry population consists of patients undergoing diagnostic cardiac catheterization for suspected CAD at hospitals without SOS and who require PCI.

Condition or disease
Coronary Artery Disease Heart Attack Angina

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 31390 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site
Actual Study Start Date : April 1, 2011
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : March 2016

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Thru Index or Transfer Hospital Discharge on average 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient population includes inpatients and outpatients undergoing diagnostic cardiac catheterization for suspected coronary artery disease (CAD) at hospitals without SOS.
Criteria

Inclusion Criteria:

Patient inclusion criteria are:

Pre-catheterization

  1. must be undergoing diagnostic cardiac catheterization for suspected CAD
  2. be at least 18 years of age
  3. must not be pregnant (negative pregnancy test) or must not be of childbearing potential
  4. must be able to give informed consent. Post-catheterization
  5. coronary artery disease judged to be clinically and angiographically significant
  6. ability to perform PCI with equipment available at the local site (see below)
  7. procedure risk judged to be not high (see below)

Exclusion Criteria:

Patient exclusion criteria are:

Pre-catheterization

  1. inability to give informed consent
  2. ST-segment elevation myocardial infarction
  3. pregnancy Post-catheterization
  4. high likelihood of requiring a device not available at the hospitals without SOS (see below)
  5. no need for PCI
  6. need for coronary artery bypass surgery
  7. high procedural risk (see below)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137980


Locations
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Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Thomas Aversano, MD Johns Hopkins University
More Information
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Additional Information:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02137980    
Other Study ID Numbers: NA_00046362
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases