- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01625104
Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI (RAPID-PCI)
Randomized Trial of Aggressive Process of Care Quality Improvement Intervention to Decrease Door to Balloon Time in Primary PCI for Acute Myocardial Infarction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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".
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: Aggressive Intervention Strategy
Hospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following:
|
|
Placebo Comparator: Group 2: Control Strategy
Hospitals randomized to the control group were instructed to conduct "business as usual".
|
Business as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Sites With Reduction in Door to Balloon Time
Time Frame: Arrival to balloon inflation, measured in minutes (generally less than 120 mins)
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mauro Moscucci, M.D., University of Michigan
- Study Director: Eva M Kline-Rogers, MS, RN, University of Michigan
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1998-0080
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.
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