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NCT00781118 · ClinicalTrials.gov registry record · Phase 3
AngelMed for Early Recognition and Treatment of STEMI
A Phase 3 study, sponsored by Angel Medical Systems.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,020
- Enrollment target
NCT00781118 is a Phase 3 study that has completed, run by Angel Medical Systems. The registered enrollment target is 1,020 participants.
The verdict
NCT00781118, a Phase 3 study, has completed, sponsored by Angel Medical Systems.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,020 participants
- Enrollment target
Study Summary
A prospective, randomized multicenter study of subjects with a high-risk of having a myocardial infarction (MI) due to acute coronary syndrome or bypass surgery. There is no differential intervention administered to the two arms of the ALERTS Study. The study evaluates whether or not a patient alarm from the Guardian System will provide benefit (e.g. shorten pre-hospital delay) compared to symptoms-only ER presentation in the event of a heart attack. An amendment to the data analysis protocol was collaboratively created by AngelMed and FDA, and was adopted by AngelMed on 4/22/2017.
Interventions
- DEVICE Guardian System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,020 participants |
| Start Date | 2008-12 |
| Est. Completion | 2017-05-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00781118
The ClinicalTrials.gov registry entry for NCT00781118 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,020 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Angel Medical Systems, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Guardian System is the first listed.
NCT00781118 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00781118 about?
NCT00781118 is a clinical study titled "AngelMed for Early Recognition and Treatment of STEMI". A prospective, randomized multicenter study of subjects with a high-risk of having a myocardial infarction (MI) due to acute coronary syndrome or bypass surgery. There is no differential intervention administered to the two arms of the ALERTS Study. The study evaluates whether or not a patient alarm...
What is the current status of trial NCT00781118?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,020 participants. The study started on 2008-12. Estimated completion is 2017-05-17.
What interventions are being tested in trial NCT00781118?
The interventions under investigation include: Guardian System (DEVICE).
Who is sponsoring clinical trial NCT00781118?
This trial is sponsored by Angel Medical Systems, which has 3 total clinical trials registered on ClinicalTrials.gov.
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