Stent Thrombosis In Acute Coronary Syndromes

Completed

• Conditions: Stent Thrombosis; Acute Coronary Syndrome

• Registration Number: NCT00931502
• Lead Sponsor: University of California, Davis

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-30
• Study First Posted: 2009-07-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe current real world practice in the treatment of ACS due to stent thrombosis.	3 years

Secondary Outcome Measures

Name	Time	Method
To describe early and long term follow up of patients who are treated for ACS due to stent thrombosis.	3 years

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States