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

NCT ID: NCT00842374

Last Updated: 2013-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-STEMI Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-STEMI ACS

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Medicines Company

INDUSTRY

Sponsor Role collaborator

Minneapolis Heart Institute Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David M Larson, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute Foundation

Locations

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Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15911720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17679616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17673457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16169311 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15523305 (View on PubMed)

Related Links

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http://www.mplsheart.org/

Minneapolis Heart Institute Foundation

Other Identifiers

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acs001

Identifier Type: -

Identifier Source: org_study_id

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