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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014