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

This study has been completed.
Sponsor:
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT00842374
First received: February 11, 2009
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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
Non-STEMI Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin

Resource links provided by NLM:


Further study details as provided by Minneapolis Heart Institute Foundation:

Primary Outcome Measures:
  • Incidence of MACE defined as any one of the following: • Acute myocardial infarction/reinfarction • Ischemia-driven unplanned revascularizations • Stroke • All cause Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rehospitalization for ACS [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 30 days, one year and up to 5 years ] [ Designated as safety issue: No ]
  • Major Bleeding [ Time Frame: in hospital and at 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: December 2008
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-STEMI ACS

  Eligibility

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

Emergency Department

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842374

Locations
United States, Minnesota
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
  More Information

Additional Information:
Publications:
Gibler WB, Cannon CP, Blomkalns AL, Char DM, Drew BJ, Hollander JE, Jaffe AS, Jesse RL, Newby LK, Ohman EM, Peterson ED, Pollack CV; American Heart Association Council on Clinical Cardiology (Subcommittee on Acute Cardiac Care); Council on Cardiovascular Nursing, and Quality of Care and Outcomes Research Interdisciplinary Working Group; Society of Chest Pain Centers. Practical implementation of the guidelines for unstable angina/non-ST-segment elevation myocardial infarction in the emergency department: a scientific statement from the American Heart Association Council on Clinical Cardiology (Subcommittee on Acute Cardiac Care), Council on Cardiovascular Nursing, and Quality of Care and Outcomes Research Interdisciplinary Working Group, in Collaboration With the Society of Chest Pain Centers. Circulation. 2005 May 24;111(20):2699-710.
Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation. 2007 Aug 14;116(7):e148-304. Epub 2007 Aug 6. No abstract available. Erratum in: Circulation. 2008 Mar 4;117(9):e180.

Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT00842374     History of Changes
Other Study ID Numbers: acs001
Study First Received: February 11, 2009
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Bivalirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014