Myocardial InfarctionNCT00682526
Pre-Hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-Held Device
An observational study of Myocardial Infarction, run by Welch Allyn at 7 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- SmartLink Wireless Monitoring System (K033642)
- Type of treatment
- Medical device
- How many people
- 527 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2003to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- All patients with a diagnosis of acute STEMI defined as 1 mm ST segment elevation in two spatially contiguous leads were included. There were two major subgroups: emergency medical services (EMS) and self-transport patients. Self-transport patients, who did not have PH-ECG transmission, served as a comparison group.
Who cannot join
- Less than age 18
- No intent to undergo reperfusion therapy (PCI or thrombolytics)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Bethesda North Hospital
Cincinnati, Ohio, 45242
Durham Regional Hospital
Durham, North Carolina, 27704
Duke University Medical Center
Durham, North Carolina, 27705
Shands @ AGH
Gainesville, Florida, 32605
South Miami Heart Center
Miami, Florida, 33143
University of Pittsburgh Medical Center - Presbyterian
Pittsburgh, Pennsylvania, 15213
Salinas Valley Memorial Healthcare System
Salinas, California, 93901
About this study
Official title: Pre-hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-held Device: The TIME Multicenter Study
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).
Read more
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: Patient characteristics for the three periods were compared with the chi-square statistic for categorical variables and one-way analysis of variance for age. The Wilcoxon rank-sum statistic was used to compare time-to-reperfusion in the pre-study and study periods as well as in the Group 1 post-study period. Comparisons were performed separately for EMS and self-transport groups.
- Conditions
- Myocardial Infarction
- Being tested
- SmartLink Wireless Monitoring System (K033642)
- Keywords
- EMS patients with intention to treat with coronary reperfusion therapy (PCI or thrombolytics) based on their initial presentation
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartLink Wireless Monitoring System (K033642)Device
Also called Wireless transmission of ECG with intention to treat with coronary reperfusion therapy.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-study Period (Group 1 and Group 2). | The TIME-MC study was conducted from June 2003 to June 2008 at NEMC (Figure 1) and from May 2005 to September 2008 at the six larger medical centers (Figure 2). Two groups were studied. Group 1 included patients at NEMC and Group 2 included patients at the other six medical sites. The study was divided into three periods: Pre-study period (Group 1 and Group 2). No PH-ECG transmission system was available. | |
| Study Period (Group 1 and Group 2) | Study period (Group 1 and Group 2). PH-ECG transmission to a cardiologist's hand-held device was attempted through pre-assigned EMS ambulances equipped with a wireless ECG transmission device in addition to a STEMI code system. In Group 1, this referred to the pilot study at NEMC from June 2003 to May 2005. Receives: Device: SmartLink Wireless Monitoring System (K033642) | |
| Post-study period (Group 1) | Post-study period (Group 1). PH-ECG transmission and a STEMI code system implemented after the pilot study period. Receives: Device: SmartLink Wireless Monitoring System (K033642) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Door to intervention time - time from emergency department door time until intervention.
Measured: time from emergency department door time until intervention.
Secondary outcomes (4)
Salvaged myocardial tissue - pre-hospital ECGs will be read using the Aldrich final MI size prediction to calculate the size of infarct that would be expected to result without reperfusion treatment.
Measured: pre hospital ECG - discharge ECG
Aborted infarction-defined as combined ECG and cardiac biomarkers criteria:1.subsiding of ST deviation greater than or equal to 50% within 2 hours after reperfusion treatment. 2.rise in cardiac enzymes less than or equal to 2 times upper value of normal.
Measured: 2 hours after reperfusion treatment
Hospital mortality - whether the patient was discharged alive.
Measured: discharge
No infarct related artery at time of heart catheterization.
Measured: catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startJun 2003
- Primary completionSep 2008
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Welch Allyn
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Galen S Wagner, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682526
- Sponsor's protocol ID
- TIME Multicenter Study
- Status last verified
- Feb 2012
- First submitted
- 12 May 2008
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Adams G, Abusaid G, Lee B, Maynard C, Campbell P, Wagner G, Barbagelata A. From theory to practice: implementation of pre-hospital electrocardiogram transmission in ST-elevation myocardial infarction - a multicenter experience. J Invasive Cardiol. 2010 Nov;22(11):520-5.
PubMed 21041847
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-held Device: The TIME Multicenter Study
- ClinicalTrials.gov ID
- NCT00682526
- Acronym / sponsor ID
- TIME Multicenter Study
- Conditions
- Myocardial Infarction
- Keywords
- EMS patients with intention to treat with coronary reperfusion therapy (PCI or thrombolytics) based on their initial presentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Welch AllynIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- Jun 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: Patient characteristics for the three periods were compared with the chi-square statistic for categorical variables and one-way analysis of variance for age. The Wilcoxon rank-sum statistic was used to compare time-to-reperfusion in the pre-study and study periods as well as in the Group 1 post-study period. Comparisons were performed separately for EMS and self-transport groups.
Study design
- Observational model
- Case-control
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-study Period (Group 1 and Group 2). | – | –The TIME-MC study was conducted from June 2003 to June 2008 at NEMC (Figure 1) and from May 2005 to September 2008 at the six larger medical centers (Figure 2). Two groups were studied. Group 1 included patients at NEMC and Group 2 included patients at the other six medical sites. The study was divided into three periods: Pre-study period (Group 1 and Group 2). No PH-ECG transmission system was available. |
| Study Period (Group 1 and Group 2) | – | Device: SmartLink Wireless Monitoring System (K033642)Study period (Group 1 and Group 2). PH-ECG transmission to a cardiologist's hand-held device was attempted through pre-assigned EMS ambulances equipped with a wireless ECG transmission device in addition to a STEMI code system. In Group 1, this referred to the pilot study at NEMC from June 2003 to May 2005. |
| Post-study period (Group 1) | – | Device: SmartLink Wireless Monitoring System (K033642)Post-study period (Group 1). PH-ECG transmission and a STEMI code system implemented after the pilot study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- All patients with a diagnosis of acute STEMI defined as 1 mm ST segment elevation in two spatially contiguous leads were included. There were two major subgroups: emergency medical services (EMS) and self-transport patients. Self-transport patients, who did not have PH-ECG transmission, served as a comparison group.
Key exclusion criteria (2 listed)
- Less than age 18
- No intent to undergo reperfusion therapy (PCI or thrombolytics)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartLink Wireless Monitoring System (K033642)Also: Wireless transmission of ECG with intention to treat with coronary reperfusion therapy.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. | Device | Post-study period (Group 1), Study Period (Group 1 and Group 2) |
Primary outcome
Door to intervention time - time from emergency department door time until intervention.
Time frame: time from emergency department door time until intervention.
4 secondary outcomes
Salvaged myocardial tissue - pre-hospital ECGs will be read using the Aldrich final MI size prediction to calculate the size of infarct that would be expected to result without reperfusion treatment.
Time frame: pre hospital ECG - discharge ECG
Aborted infarction-defined as combined ECG and cardiac biomarkers criteria:1.subsiding of ST deviation greater than or equal to 50% within 2 hours after reperfusion treatment. 2.rise in cardiac enzymes less than or equal to 2 times upper value of normal.
Time frame: 2 hours after reperfusion treatment
Hospital mortality - whether the patient was discharged alive.
Time frame: discharge
No infarct related artery at time of heart catheterization.
Time frame: catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
- Results publication: PubMed 21041847Adams G, Abusaid G, Lee B, Maynard C, Campbell P, Wagner G, Barbagelata A. From theory to practice: implementation of pre-hospital electrocardiogram transmission in ST-elevation myocardial infarction - a multicenter experience. J Invasive Cardiol. 2010 Nov;22(11):520-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galen S Wagner, MD principal investigator
Duke University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Welch Allyn at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Door to intervention time - time from emergency department door time until intervention. (time frame: time from emergency department door time until intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00682526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2012.