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Improving Door-to-Balloon Time in STEMI (EHART)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by St. Francis Hospitals & Health Centers.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St. Francis Hospitals & Health Centers
ClinicalTrials.gov Identifier:
NCT00800163
First received: November 26, 2008
Last updated: July 22, 2010
Last verified: November 2008
History of Changes
  Purpose

The investigators prospectively determined the impact on median door-to-balloon time of a protocol mandating (1) emergency department physician activation of the catheterization lab and (2) immediate transfer of the patient to an immediately available catheterization lab by an in-house transfer team consisting of an emergency department nurse, a critical care unit nurse, and a chest pain unit nurse.


Condition Intervention
Myocardial Infarction
 Other: ED Activation/Immediate Transfer

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Emergency Department Physician Activation of the Catheterization Laboratory and Immediate Transfer to an Immediately Available Catheterization Lab Reduce Door-to-Balloon Time in ST-Elevation Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by St. Francis Hospitals & Health Centers:

Primary Outcome Measures:
  • Door-to-Balloon Time [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infarct Size [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • In-Hospital Mortality [ Time Frame: ~ 7 days (during index hospitalization) ] [ Designated as safety issue: No ]
  • Hospital Length of Stay [ Time Frame: ~2-7 days (during index hospitalization) ] [ Designated as safety issue: No ]
  • Hospital Costs [ Time Frame: ~2-7 days (during Index Hospitalization) and One Year Followup ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: September 2005
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ED Physician Activation/Immediate Transfer Other: ED Activation/Immediate Transfer
ED Physician Activation and Immediate Transfer Protocol - see Circulation. 2007;116:67-76

Detailed Description:

Please see Circulation. 2007;116:67-76

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Primary Study Inclusion Criteria:

  • ST-elevation myocardial infarction patients who undergo percutaneous intervention within 24 hours of ED arrival

Exclusion Criteria:

  • Patients who are inpatients

A registry of all patients who undergo emergency cardiac catheterization irrespective of etiology is maintained.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800163

Contacts
Contact: Umesh N Khot, M.D. 317-893-1666 khot@cvresearch.net
Contact: Michele Johnson-Wood, R.N 317-851-2875 Michele.Johnson-Wood@ssfhs.org

Locations
United States, Indiana
St. Francis Heart Center Recruiting
Indianapolis, Indiana, United States, 46259
Contact: Umesh N. Khot, M.D.     317-893-1666     khot@cvresearch.net    
Sponsors and Collaborators
St. Francis Hospitals & Health Centers
Investigators
Principal Investigator: Umesh N Khot, M.D. Indiana Heart Physicians/St. Francis Heart Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Umesh N. Khot, M.D., Indiana Heart Physicians/St. Francis Heart Center
ClinicalTrials.gov Identifier: NCT00800163     History of Changes
Other Study ID Numbers: St. Francis Heart Center-EHART
Study First Received: November 26, 2008
Last Updated: July 22, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013