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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01625104
Other study ID # 1998-0080
Secondary ID
Status Completed
Phase N/A
First received June 19, 2012
Last updated May 15, 2017
Start date September 2003
Est. completion date December 2006

Study information

Verified date May 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to assess whether an aggressive quality improvement intervention strategy will decrease time from hospital presentation to first balloon inflation in non-transfer patients with acute ST segment elevation MI (STEMI) treated with primary percutaneous coronary intervention (PCI). Twelve hospitals in Michigan were randomized to either aggressive intervention or control. The intervention consisted of Grand Rounds at each hospital, sharing of best practices, and coordinating center staff working closely with staff at each intervention hospital to discuss solutions to barriers to rapid treatment for STEMI patients.


Description:

The participating hospitals randomized to the aggressive intervention strategy actively worked to create teams to analyze processes of care for STEMI patients, identify areas needing improvement, and implemented strategies to streamline treatment.

Hospitals randomized to control were instructed to conduct "business as usual".


Recruitment information / eligibility

Status Completed
Enrollment 882
Est. completion date December 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Acute ST segment myocardial infarction, non transfer patients, with symptom onset to balloon time less than or equal to 24 hours.

Exclusion Criteria:

- Patients transferred from one facility to another,

- non ST segment myocardial infarction patients.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non Intervention
Business as usual
Agressive Intervention Process Improvement Strategies


Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Sites With Reduction in Door to Balloon Time Arrival time in Emergency Department to first balloon inflation in the coronary artery.
Any reduction in median Door to Balloon Time from baseline to follow-up was counted as reduction in time
Arrival to balloon inflation, measured in minutes (generally less than 120 mins)
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