Registry Experience at the Washington Hospital Center, DES - Endeavor for Myocardial Infarction (REWARDS-EMI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01003717
First received: October 20, 2009
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

Single-center registry of patients treated with at least one Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome at the Washington Hospital Center, with the aim of assessing clinical success and safety at 30 days, 6 months and annually for up to 3 years post Endeavor Stent implantation.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: REWARDS-EMI (Registry Experience at the Washington Hospital Center, DES - Endeavor for Myocardial Infarction)

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • Evaluation of Major Adverse Cardiac Events following implantation of at least one Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome [ Time Frame: Follow Up ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Endeavor
Patients treated with at least 1 Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome

Detailed Description:

Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES).Zotarolimus-eluting stents have shown promising results in randomized clinical trails, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with Sirolimus-eluting stents. While short-term and 1 year registry data is available from outside of the United States, it will be important to collect "real-world" data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Endeavor® Stent as primary treatment for ACS for up to 3 years post initial stent implantation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who receive at least one Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome, at the Washington Hospital Center.

Criteria

Inclusion Criteria:

  • Patients, male or female, >18 years of age
  • Patients presenting with acute coronary syndrome (ACS), where ACS is defined as ST segment deviation of >1mm or an elevation of the isoenzymes greater than 2x upper limit of normal
  • Patients who received at least one Endeavor drug-eluting stent at the Washington Hospital Center

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003717

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Research Institute/Cardiovascular Research Institute
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01003717     History of Changes
Other Study ID Numbers: REWARDS EMI
Study First Received: October 20, 2009
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 01, 2014