Stent Thrombosis In Acute Coronary Syndromes

NCT ID: NCT00931502

Last Updated: 2018-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2017-02-28

Brief Summary

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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

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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.

Conditions

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Stent Thrombosis Acute Coronary Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Rogers, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Khung Keong Yeo, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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UC Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

References

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Reeves RR, Patel M, Armstrong EJ, Sab S, Waldo SW, Yeo KK, Shunk KA, Low RI, Rogers JH, Mahmud E. Angiographic characteristics of definite stent thrombosis: role of thrombus grade, collaterals, epicardial coronary flow, and myocardial perfusion. Catheter Cardiovasc Interv. 2015 Jan 1;85(1):13-22. doi: 10.1002/ccd.25519. Epub 2014 May 7.

Reference Type DERIVED
PMID: 24753053 (View on PubMed)

Waldo SW, Armstrong EJ, Yeo KK, Patel M, Reeves R, Macgregor JS, Low RI, Mahmud E, Rogers JH, Shunk K. Procedural success and long-term outcomes of aspiration thrombectomy for the treatment of stent thrombosis. Catheter Cardiovasc Interv. 2013 Dec 1;82(7):1048-53. doi: 10.1002/ccd.25007. Epub 2013 Jul 2.

Reference Type DERIVED
PMID: 23703925 (View on PubMed)

Armstrong EJ, Yeo KK, Javed U, Mahmud E, Patel M, Shunk KA, MacGregor JS, Low RI, Rogers JH. Angiographic stent thrombosis at coronary bifurcations: short- and long-term prognosis. JACC Cardiovasc Interv. 2012 Jan;5(1):57-63. doi: 10.1016/j.jcin.2011.09.015.

Reference Type DERIVED
PMID: 22230151 (View on PubMed)

Other Identifiers

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STR 001

Identifier Type: -

Identifier Source: secondary_id

214693

Identifier Type: OTHER

Identifier Source: secondary_id

214693

Identifier Type: -

Identifier Source: org_study_id

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