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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: Completed Phase 3 study, sponsored by Angel Medical Systems.
NCT00781118 is a Phase 3 study that has completed, run by Angel Medical Systems. The registered enrollment target is 1,020 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
With Amendment the primary efficacy objective was amended to be a co-primary endpoint which included A) a hypothesis test of superiority for positive predictive value of ER visits in the ALARMS\_ON group due to Guardian alerting (with or without concurrent symptoms) compared to ER visits in the ALARMS\_OFF group due to symptoms only; AND B) a hypothesis test of non-inferiority for rate of false positive ER visits in the ALARMS\_ON group due to Guardian alerting (with or without concurrent sympto
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 |
What the finished NCT00781118 record still lists
NCT00781118 is an interventional study that assigns participants to a tested intervention. Its 1,020 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 1 intervention - of which Guardian System is the first listed.
NCT00781118 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00781118's enrollment target sits among peer trials
1,020 291st of 2000 higher than 1,708 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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