AngelMed for Early Recognition and Treatment of STEMI

Completed · Phase 3

Conditions studied: Acute Myocardial Infarction (AMI), Coronary Occlusion, Acute Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT00781118

Run by

Angel Medical Systems

People needed

1020

Starts

2008-12-01

Expected to finish

2017-05-17

Last updated by the study team

2018-03-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has at least one of the following conditions:
• Diabetes (Type I or Type II)
• Compromised renal function (Cr > 1.2 mg/dl or creatinine clearance less than 50)
• TIMI Risk Score ≥ 3
• Presents (within past 6 months) with a high-risk acute coronary syndrome (e.g., Unstable Angina, STEMI or NSTEMI) or has undergone or is scheduled for CABG within 6 months of implantation.
• Has already undergone coronary angiography and revascularization, unless the physician determines it is appropriate to implant before or during the planned procedure.
• Lives in a geographic area in close proximity (within 60 minutes by EMS) to any hospital that can treat AMI.
• Subjects (men or women) at least 21 years of age. Women of childbearing age must have a negative pregnancy test or confirmation of one of the following:
• Post-menopause or amenorrheic during the past year
• Surgical sterilization
• Use of effective contraceptive method

You may not qualify if…

• In the investigator's opinion, subject lacks ability to respond appropriately to alarms, e.g., illiteracy, poor memory or cognitive function, dementia or other condition affecting memory function, etc.
• There is known compromised tissue at the site of lead implantation in the apex of the right ventricle, e.g., prior infarct affecting the RV apex location.
• A permanent pacemaker or ICD is already in place or the patient is indicated for ICD or pacemaker implantation based on the guidelines published by the American College of Cardiology as Class I and IIa recommendations. Class IIb recommendations are at the investigator's discretion.
• Subject cannot feel the IMD vibration when placed on top of the skin on the left pectoral side of the chest.
• Subject has recurrent or persistent atrial fibrillation.
• Subject has recurrent or persistent non-sinus cardiac rhythm, second or third degree atrioventricular blocks, QRS duration greater than 120 ms, Benign Early Repolarization (BER), or Brugada Syndrome.
• Subject has left ventricular hypertrophy evidenced by EKG criteria.
• Subject has any condition preventing the subcutaneous implantation of the Guardian System in a left pectoral pouch, such as: superior vena cava thrombosis, subcutaneous tissue deemed inappropriate for the procedure or prior central venous access via portacath, Hickman, Groshong, or similar placed in a left pectoral location or left side PICC line.
• Subject has extremely heavy alcohol consumption (participates in binge drinking that leads to alcohol intoxication) or has history of alcohol or illicit drug abuse within past 5 years.
• There is evidence of unresolved infection (fever > 38° C and/or leukocytosis > 15,000).
• Subject has history of bleeding disorders or severe coagulopathy (platelets < 100,000 plts/ml; APTT or PT > 1.3 x reference range).
• Subject has had a hemorrhagic stroke or transient ischemic attack (TIA) in the past 6 months.
• Subject has other severe diseases, such as cancer or refractory congestive heart failure, associated with limitation of life expectancy (less than 1 year), which may lead to inadequate compliance to the protocol or confusing data interpretation.
• Subject has clinical conditions such as heart diseases, difficult-to-control blood pressure, difficult-to-control insulin-dependent diabetes or serious prior infections attributed to the diabetes, or others that, at the investigator's discretion, could seriously affect the subject's current clinical condition during study procedures.
• Subject has previous participation in the DETECT Study, current participation or previous participation in another drug or device study in the past 30 days that conflicts with this study as determined by the study sponsor.
• Subject has experienced gastro-intestinal hemorrhage in the past 6 months.
• Subject has any situation in which the use of aspirin is contraindicated for at least 6 months.
• Subject has epilepsy.
• Subject has known severe allergies, e.g., peanut, bee sting, etc.

Where it is running

• Heart Center Research/Huntsville Hospital — Huntsville, Alabama, United States
• Banner Heart Hospital — Mesa, Arizona, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• Southwest Heart Group — Tucson, Arizona, United States
• John Muir Clinical Research Center — Concord, California, United States
• California Clinical Research Foundation — Glendale, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Mission Internal Medical Group — Mission Viejo, California, United States
• Orange County Heart Institute and Research Center Hospital — Orange, California, United States
• Huntington Memorial Hospital — Pasadena, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Sutter Memorial Hospital — Sacramento, California, United States
• Salinas Valley Memorial Hospital — Salinas, California, United States
• Radiant Research — Santa Rosa, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Bay Pines VA Healthcare System — Bay Pines, Florida, United States
• Daytona Heart Group — Daytona Beach, Florida, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• NorthFL/South GA VA Health System — Gainesville, Florida, United States
• Mercy Research Institute — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• New Phase Clinical Trials — Miami Beach, Florida, United States
• Complete Cardiology Care — New Smyrna Beach, Florida, United States
• East Coast Institute for Research — Saint Augustine, Florida, United States
• Cardiology, P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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