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AngelMed for Early Recognition and Treatment of STEMI

NCT00781118 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1020

Last updated 2018-03-14

No results posted yet for this 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.

Conditions

  • Acute Myocardial Infarction (AMI)
  • Coronary Occlusion
  • Acute Coronary Syndrome

Interventions

DEVICE

Guardian System

There is no intervention in this study. The device is a diagnostic only.

Sponsors & Collaborators

  • Symbios Clinical

    collaborator OTHER

  • Angel Medical Systems

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2014-05-01
Completion
2017-05-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00781118 on ClinicalTrials.gov