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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005677
First Posted: May 26, 2000
Last Update Posted: January 13, 2016
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pittsburgh
  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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT00005677


Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Sheryl F Kelsey, PhD University of Pittsburgh
Principal Investigator: Jeffery Popma Medlantic Research Institute
  More Information

Publications:

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 ( U.S. NIH Grant/Contract )
HL33292
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: January 13, 2016
Last Verified: January 2016

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