Percutaneous Transluminal Coronary Angioplasty (PTCA) Registries I, II, and III and the Dynamic Registry

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00005677
First received: May 25, 2000
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

To evaluate the long-term efficacy of percutaneous transluminal coronary angioplasty (PTCA) and alternative angioplasty devices in patients with coronary heart disease. There are four registries. The first registry followed 3,079 patients who received PTCA between 1977 and 1982. The second registry followed 1,500 patients from the first registry for a minimum of five years and followed 2,000 newly entered patients who received PTCA in 1985 and 1986 so that the second cohort would also be followed for five years. The third registry, the New Approaches to Coronary Intervention (NACI), followed approximately 4,424 patients between November 1990 and February 1997. The dynamic evaluation study will follow a total of 6,000 procedures.


Condition
Cardiovascular Diseases
Coronary Disease
Heart Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Evaluation of Coronary Intervention

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Death and MI [ Time Frame: 1-year and 5-years ] [ Designated as safety issue: Yes ]
    Time to death or non-fatal MI was assessed at 1-year in all recruitment waves and at 5-years in only the recruitment waves that had extended follow-up


Secondary Outcome Measures:
  • Repeat PCI and Repeat Revascularization [ Time Frame: 1-year and 5-years ] [ Designated as safety issue: No ]
    Time to repeat percutaneous coronary intervention and need for any repeat revascularization (repeat PCI + coronary artery bypass graft surgery) by 1-year for all recruitment waves and by 5-years for recruitment waves with extended follow-up


Other Outcome Measures:
  • Stent thrombosis [ Time Frame: within 30 days and beyond 30-days ] [ Designated as safety issue: Yes ]
    Acute stent thrombosis occurs within 30-days of stent placement and late stent thrombosis occurs after 30-days within a stent placed during the index PCI


Enrollment: 4290
Study Start Date: August 1980
Study Completion Date: January 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with coronary heart disease who have undergone percutaneous transluminal coronary angioplasty (PTCA) and have alternative angioplasty devices

Criteria

Inclusion Criteria:

  • Coronary heart disease
  • Undergone percutaneous transluminal coronary angioplasty (PTCA)
  • Have alternative angioplasty devices
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005677

Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Katherine Detre University of Pittsburgh
Principal Investigator: Jeffery Popma Medlantic Research Institute
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00005677     History of Changes
Other Study ID Numbers: 1023, U01HL033292, HL33292
Study First Received: May 25, 2000
Last Updated: July 11, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 30, 2014