Clinical trial NCT00931502: Stent Thrombosis In Acute Coronary Syndromes
Official title: Contemporary Treatment Of Stent Thrombosis In Acute Coronary Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stent Thrombosis
Acute Coronary Syndrome
Keywords: Stent thrombosis
Acute Coronary Syndrome
ACS
Stenting
Interventional Cardiology
Cardiology
Cardiovascular Research
Registry
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2009-07-02
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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.

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.

Primary outcomes:
measure: To describe current real world practice in the treatment of ACS due to stent thrombosis.
timeFrame: 3 years
Secondary outcomes:
measure: To describe early and long term follow up of patients who are treated for ACS due to stent thrombosis.
timeFrame: 3 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Jason Rogers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Khung Keong Yeo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.