Stent Thrombosis In Acute Coronary Syndromes

Acute Coronary Syndrome Clinical Trial

Official title:

Contemporary Treatment Of Stent Thrombosis In Acute Coronary Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931502
• Other study ID #: 214693
• Secondary ID: STR 001214693
• Status: Completed
• Phase: N/A
• First received: June 29, 2009
• Last updated: March 1, 2018
• Start date: April 2008
• Est. completion date: February 2017

Study information

• Verified date: March 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Stent Thrombosis
• Syndrome
• Thrombosis

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe current real world practice in the treatment of ACS due to stent thrombosis.		3 years
Secondary	To describe early and long term follow up of patients who are treated for ACS due to stent thrombosis.		3 years