Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin
April 24, 2013 updated by: Minneapolis Heart Institute Foundation
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Emergency Department
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Non-STEMI ACS
|
What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rehospitalization for ACS
Time Frame: 30 days
|
30 days
|
|
All cause mortality
Time Frame: 30 days, one year and up to 5 years
|
30 days, one year and up to 5 years
|
|
Major Bleeding
Time Frame: in hospital and at 30 days
|
in hospital and at 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David M Larson, MD, Minneapolis Heart Institute Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Circulation. 2008 Mar 4;117(9):e180.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
February 11, 2009
First Submitted That Met QC Criteria
February 11, 2009
First Posted (Estimate)
February 12, 2009
Study Record Updates
Last Update Posted (Estimate)
April 25, 2013
Last Update Submitted That Met QC Criteria
April 24, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- acs001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.