Non-STEMI Acute Coronary Syndrome Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 32 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Ridgeview Medical Center | Waconia | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Minneapolis Heart Institute Foundation | The Medicines Company |
United States,
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. Erratum in: Circulation. 2008 Mar 4;117(9):e180. — View Citation
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Henry TD, Sharkey SW, Burke MN, Chavez IJ, Graham KJ, Henry CR, Lips DL, Madison JD, Menssen KM, Mooney MR, Newell MC, Pedersen WR, Poulose AK, Traverse JH, Unger BT, Wang YL, Larson DM. A regional system to provide timely access to percutaneous coronary intervention for ST-elevation myocardial infarction. Circulation. 2007 Aug 14;116(7):721-8. Epub 2007 Aug 1. — View Citation
Henry TD, Unger BT, Sharkey SW, Lips DL, Pedersen WR, Madison JD, Mooney MR, Flygenring BP, Larson DM. Design of a standardized system for transfer of patients with ST-elevation myocardial infarction for percutaneous coronary intervention. Am Heart J. 2005 Sep;150(3):373-84. — View Citation
Stone GW, Bertrand M, Colombo A, Dangas G, Farkouh ME, Feit F, Lansky AJ, Lincoff AM, Mehran R, Moses JW, Ohman M, White HD. Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial: study design and rationale. Am Heart J. 2004 Nov;148(5):764-75. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of MACE defined as any one of the following: • Acute myocardial infarction/reinfarction • Ischemia-driven unplanned revascularizations • Stroke • All cause Mortality | 30 days | No | |
| Secondary | Rehospitalization for ACS | 30 days | No | |
| Secondary | All cause mortality | 30 days, one year and up to 5 years | No | |
| Secondary | Major Bleeding | in hospital and at 30 days | Yes |