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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 18, 2014
First Posted Date May 14, 2014
Last Update Posted Date April 12, 2018
Actual Study Start Date April 1, 2011
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2014)
Number of participants with adverse events [ Time Frame: Thru Index or Transfer Hospital Discharge on average 24 hours ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site
Official Title Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 1 Week
Biospecimen Not Provided
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.
Condition
  • Coronary Artery Disease
  • Heart Attack
  • Angina
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 10, 2018)
31390
Original Estimated Enrollment
 (submitted: May 13, 2014)
28000
Actual Study Completion Date March 2016
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02137980
Other Study ID Numbers NA_00046362
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators Not Provided
Investigators
Principal Investigator: Thomas Aversano, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date April 2018