Clincosm LogoSign in Get a demo

Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin

Sponsor
Minneapolis Heart Institute Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT00842374
Collaborator
The Medicines Company (Industry)
32
Enrollment
1
Location
48
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a registry of patients with non ST segment elevation Myocardial Infarction (heart attack) and/or unstable acute coronary artery syndrome treated with a standardized protocol including Bivalirudin.

Data will be collected on diagnosis, treatment and outcomes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    32 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin
    Study Start Date :
    Dec 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2011
    Actual Study Completion Date :
    Dec 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Non-STEMI ACS

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of MACE defined as any one of the following: • Acute myocardial infarction/reinfarction • Ischemia-driven unplanned revascularizations • Stroke • All cause Mortality [30 days]

    Secondary Outcome Measures

    1. Rehospitalization for ACS [30 days]

    2. All cause mortality [30 days, one year and up to 5 years]

    3. Major Bleeding [in hospital and at 30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥ 18

    • Chest pain or symptoms believed to be an anginal equivalent and representing myocardial ischemia, lasting at least 10 minutes within the past 24 hours

    • Having any one of the following:

    1. Ischemic changes on ECG: ST depression >0.5 mm OR T wave inversion >2 mm

    2. Positive cardiac markers

    3. New onset CHF presumed secondary to ischemia

    4. Pulmonary edema

    5. Known coronary artery disease with typical symptoms

    6. Hemodynamic instability

    7. Sustained ventricular tachycardia

    Exclusion Criteria:
    • For the purpose of the SSDI, patients will be excluded if we are unable to obtain their Social Security Number.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ridgeview Medical Center Waconia Minnesota United States 55387

    Sponsors and Collaborators

    • Minneapolis Heart Institute Foundation
    • The Medicines Company

    Investigators

    • Principal Investigator: David M Larson, MD, Minneapolis Heart Institute Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Minneapolis Heart Institute Foundation
    ClinicalTrials.gov Identifier:
    NCT00842374
    Other Study ID Numbers:
    • acs001
    First Posted:
    Feb 12, 2009
    Last Update Posted:
    Apr 25, 2013
    Last Verified:
    Apr 1, 2013
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome

    Study Results

    No Results Posted as of Apr 25, 2013