Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Welch Allyn Duke University |
---|---|
Information provided by: | Welch Allyn |
ClinicalTrials.gov Identifier: | NCT00682526 |
Aim: To determine the impact of wireless transmission of prehospital ECGs to a hand-held computer on time to treatment and myocardial salvage in acute MI patients.
Background: The TIME-1 investigators documented a 27% (109 to 80 minutes) reduction of time from EMT arrival at the scene to successful primary PCI implementing pre-hospital ECG transmission to the ED. ECG transmission directly to a physician's cellular phone/PDA through a wireless modem has only recently become an option. The recently completed TIME-NorthEast (NE) study tested the Welch Allyn version of this system and the results show a reduction in time to reperfusion for acute MI patients by 66 minutes (116 to 50).
Methods: This study will involve approximately 20 sites around the country. The study will be divided into two phases: a consecutive control data collection phase (Phase I) and an intervention with concurrent control phase (Phase II). Phase II will begin after installation of Welch Allyn ECG transmission equipment. The primary end-point will be time to reperfusion and secondary end-points will include myocardial salvage, aborted infarction and hospital mortality. ECG measurements will be made at a central ECG core lab by a blinded investigator.
Data Analysis: Time to reperfusion data will be analyzed on an individual site basis, whereas clinical outcomes data will be pooled from all sites. Statistical analysis will include the Wilcoxon Rank Sum Test and the two-sample t-test (if normally distributed) for continuous variables. The Chi-square test will be used to analyze categorical variables.
Condition | Intervention |
---|---|
Myocardial Infarction |
Device: SmartLink Wireless Monitoring System (K033642) |
Study Type: | Observational |
Study Design: | Case Control |
Official Title: | Pre-Hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-Held Device: The TIME Multicenter Study |
Enrollment: | 527 |
Study Start Date: | May 2001 |
Estimated Study Completion Date: | December 2008 |
Groups/Cohorts | Assigned Interventions |
---|---|
Phase I
Consecutive Control: All EMS or self transported patients age 18 or over with the intention to treat with coronary reperfusion therapy (PCI or thrombolytics) based on their initial presentation. |
|
Phase II - I
Intervention Group: All EMS transported patients age 18 or over who have their ECG attempted to be wirelessly transmitted and with the intention to treat with coronary reperfusion therapy (PCI or thrombolytics)based on their initial presentation. This group contains two subgroups:
|
Device: SmartLink Wireless Monitoring System (K033642)
All EMS transported patients age 18 or over who have their ECG attempted to be wirelessly transmitted and with the intention to treat with coronary reperfusion therapy (PCI or thrombolytics)based on their initial presentation.
|
Phase II - C
Concurrent Control: All self transported and EMS transported patients age 18 or over with the intention to undergo reperfusion therapy (PCI or thrombolytics) based on their initial presentation who do not qualify for the intervention group. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
EMS transported patients age 18 or over who have their ECG attempted to be wirelessly transmitted and with the intention to treat with coronary reperfusion therapy (PCI or thrombolytics) based on their initial presentation All self transported and EMS transported patients age 18 or over with the intention to undergo reperfusion therapy (PCI or thrombolytics)based on their initial presentation who do not qualify for the intervention group.
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Salinas Valley Memorial Healthcare System | |
Salinas, California, United States, 93901 | |
United States, Florida | |
South Miami Heart Center | |
Miami, Florida, United States, 33143 | |
Shands @ AGH | |
Gainesville, Florida, United States, 32605 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27705 | |
Durham Regional Hospital | |
Durham, North Carolina, United States, 27704 | |
Northeast Medical Center | |
Concord, North Carolina, United States, 28025 | |
United States, Ohio | |
Bethesda North Hospital | |
Cincinnati, Ohio, United States, 45242 | |
United States, Oklahoma | |
Integris Baptist Medical Center | |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center - Presbyterian | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Galen S Wagner, MD | Duke University |
Responsible Party: | Welch Allyn ( John Seller, RN ) |
Study ID Numbers: | TIME Multicenter Study |
Study First Received: | May 12, 2008 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00682526 History of Changes |
Health Authority: | United States: Institutional Review Board |
EMS patients with intention to treat with coronary reperfusion therapy (PCI or thrombolytics) based on their
initial presentation |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Fibrinolytic Agents Ischemia Infarction Myocardial Infarction |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |