Clinical trial NCT00842374: Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin
Official title: Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-STEMI Acute Coronary Syndrome
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
Collaborators: name: The Medicines Company
First posted: 2009-02-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Emergency Department

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of MACE defined as any one of the following: • Acute myocardial infarction/reinfarction • Ischemia-driven unplanned revascularizations • Stroke • All cause Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Rehospitalization for ACS
timeFrame: 30 days
measure: All cause mortality
timeFrame: 30 days, one year and up to 5 years
measure: Major Bleeding
timeFrame: in hospital and at 30 days
Other outcomes:
Locations:
city: Waconia
country: United States
facility: Ridgeview Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis Heart Institute Foundation
name: David M Larson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1161/01.CIR.0000165556.44271.BE.
citation: 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. doi: 10.1161/CIRCULATIONAHA.107.181940. Epub 2007 Aug 6. No abstract available.
citation: 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. doi: 10.1161/CIRCULATIONAHA.107.694141. Epub 2007 Aug 1.
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. doi: 10.1016/j.ahj.2005.01.059.
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. doi: 10.1016/j.ahj.2004.04.036.