Stent Thrombosis In Acute Coronary Syndromes | NCT00931502

Studies
Stent Thrombosis In Acute Coronary Syndromes

NCT00931502

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Mar 2, 2018Actual

Enrollment

800Actual

Phase

Not provided

Conditions

Stent Thrombosis
Acute Coronary Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
STR 001
214693	Other Identifier	UC Davis

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Jun 29, 2009

First Submission Date that Met QC Criteria

Jun 30, 2009

First Posted Date

Jul 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2018

Last Update Posted Date

Mar 2, 2018Actual

Name	Class
University of California, San Diego	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason Rogers, MD	University of California, Davis	Principal Investigator
Khung Keong Yeo, MD	University of California, Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Medical Center		Sacramento	California	95817	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24753053	Derived	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.
23703925

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases