Stent Thrombosis In Acute Coronary Syndromes

March 1, 2018 updated by: University of California, Davis

Contemporary Treatment Of Stent Thrombosis In Acute Coronary Syndromes

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To describe current real world practice in the treatment of ACS due to stent thrombosis.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe early and long term follow up of patients who are treated for ACS due to stent thrombosis.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

University of California, San Diego

Investigators

  • Principal Investigator: Khung Keong Yeo, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (ESTIMATE)

July 2, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 214693 (OTHER: UC Davis)
  • STR 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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