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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00842374

Enrollment

Registered

2009-02-12

Start date

2008-12-31

Completion date

2012-12-31

Last updated

2013-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-STEMI Acute Coronary Syndrome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Rehospitalization for ACS	30 days
All cause mortality	30 days, one year and up to 5 years
Major Bleeding	in hospital and at 30 days

Countries

United States

Outcome results