Stent Thrombosis In Acute Coronary Syndromes

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00931502
First received: June 29, 2009
Last updated: June 30, 2009
Last verified: June 2009
  Purpose

The purpose of this study is to better understand what treatment methods result in the best outcomes for patients who have heart attacks due to blood clots forming within stents.


Condition
Stent Thrombosis
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Contemporary Treatment Of Stent Thrombosis In Acute Coronary Syndromes

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • To describe current real world practice in the treatment of ACS due to stent thrombosis. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe early and long term follow up of patients who are treated for ACS due to stent thrombosis. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: April 2008
Detailed Description:

This is a multicenter registry that examines treatment strategies and outcomes in patients who present with acute coronary syndrome (ACS) due to stent thrombosis in the coronary arteries. This study will take place at potentially 8 medical centers throughout the State of California. A total of 800 patients will be enrolled into the registry, 100 patients from each of the eight participating California medical centers. UC Davis will serve as the core lab for this study.

Eligible subjects, patients who present to the hospital (medical center) with ACS due to stent thrombosis and receive a cardiac catheterization to treat the stent thrombosis, will be included in the retrospective analysis of this cardiac condition. Subjects who expire in hospital due to ACS with stent thrombosis will also be included in the retrospective analysis of this clinical registry. Patients, who consent for approval, will become eligible to participate in the 3-year prospective follow-up phase of the clinical registry. These patients will be followed for three years to learn more about long term clinical outcomes for this disease state.

There are no specific/special procedures required for this clinical registry. This is a registry for data collection only to correlate prescribed medical care with individual short- and long-term clinical outcomes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have had a heart attack or almost have had a heart attack due to blood clots forming within previously placed stents.

Criteria

Inclusion Criteria:

  • Subject's age range will be ≥ 18 years old.
  • Subjects will have an existing drug-eluting or bare metal stent.
  • Subjects will have presented to the Medical Center with Acute Coronary Syndrome due to stent thrombosis as identified via cardiac catheterization.

Exclusion Criteria:

  • Inability to consent/declined to participate in the prospective arm of the clinical registry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931502

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
University of California, San Diego
Investigators
Principal Investigator: Jason Rogers, MD University of California, Davis
Principal Investigator: Khung Keong Yeo, MD University of California, Davis
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Principal Investigator: Jason Rogers, MD Sub Investigator: Khung Keong Yeo, MD, UC Davis Medical Center
ClinicalTrials.gov Identifier: NCT00931502     History of Changes
Other Study ID Numbers: 200816184, STR 001
Study First Received: June 29, 2009
Last Updated: June 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Stent thrombosis
Acute Coronary Syndrome
ACS
Stenting
Interventional Cardiology
Cardiology
Cardiovascular Research
Registry

Additional relevant MeSH terms:
Thrombosis
Acute Coronary Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014