NCT00931502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 2, 2018

Status Verified

March 1, 2018

Enrollment Period

8.8 years

First QC Date

June 29, 2009

Last Update Submit

March 1, 2018

Conditions

Keywords

Stent thrombosisAcute Coronary SyndromeACSStentingInterventional CardiologyCardiologyCardiovascular ResearchRegistry

Outcome Measures

Primary Outcomes (1)

  • To describe current real world practice in the treatment of ACS due to stent thrombosis.

    3 years

Secondary Outcomes (1)

  • To describe early and long term follow up of patients who are treated for ACS due to stent thrombosis.

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to consent/declined to participate in the prospective arm of the clinical registry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jason Rogers, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR
  • Khung Keong Yeo, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2009

First Posted

July 2, 2009

Study Start

April 1, 2008

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 2, 2018

Record last verified: 2018-03

Locations