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OpenTrials
Completed

NCT Number: NCT00842374

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

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.

Completed

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Key information

Conditions

Non-STEMI Acute Coronary Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Ischemic changes on ECG: ST depression >0.5 mm OR T wave inversion >2 mm
  • Positive cardiac markers
  • New onset CHF presumed secondary to ischemia
  • Pulmonary edema
  • Known coronary artery disease with typical symptoms
  • Hemodynamic instability
  • 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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Rehospitalization for ACS

    Time frame: 30 days

  2. All cause mortality

    Time frame: 30 days, one year and up to 5 years

  3. Major Bleeding

    Time frame: in hospital and at 30 days

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Collaborators

  • The Medicines Company

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Feb 12, 2009
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.