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Completed

NCT Number: NCT02137980

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

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.

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Key information

Conditions

Coronary Artery Disease Angina Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Attack Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Crestwood Medical Center, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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)

Exclusion criteria

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)
  • no need for PCI
  • need for coronary artery bypass surgery
  • high procedural risk (see below)

Treatment and study plan

Primary outcomes

  1. Number of participants with adverse events

    Time frame: Thru Index or Transfer Hospital Discharge on average 24 hours

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: CPORT

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
May 14, 2014
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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