Electrophysiology - ALERTS

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Trial Sponsor
Angel Medical Systems

Principal Investigator
Ziad Issa, MD

Trial Name
AngelMed for Early Recognition and Treatment of STEMI

Purpose
This study is a prospective, randomized multicenter study of subjects that are high-risk of having a myocardial infarction (heart attack) due to having a recent episode of chest pain that was uncontrolled with medication and required additional treatment (acute coronary syndrome) or have had open heart surgery (bypass surgery).

Details
There are over one million people in the United States each year that suffer a heart attack. Of those one million people, approximately 400,000 of those individuals die. Early identification of an acute MI or heart attack along with prompt treatment has been shown to significantly improve a patient’s outcomes. Experimental and clinical studies have shown that most of the irreversible damage to the heart muscle occurs during the first two hours after a blockage in a heart artery occurs. Therefore, the earlier the arrival of a patient at the hospital for diagnosis and treatment the better chance the patient has for an improved outcome after a heart attack.

It has been noted that patients do not recognize their symptoms initially and do not immediately seek treatment. For example, patients expect the type of heart attack that they often see in movies or on television: the kind of crushing chest pain that drops a person to the ground. The reality is that many heart attacks are much "quieter," causing only mild chest pain or discomfort or other symptoms such as shortness of breath or diaphoresis.

If patients were able recognize their symptoms early or have an early warning system, treatment would be started much sooner and their outcomes could possibly be improved. A potentially ideal solution is to implant the Angel Medical Guardian device that measures heart signals from inside the heart and will alert the patient when it detects possible abnormalities predetermined by their physician that needs to be checked or evaluated.

Ages eligible for the study
21 years or older

Genders eligible for the study
Both

Inclusion Criteria

• Subject has at least one of the following conditions:
  • 1. Diabetes
  • 2. Poor kidney function defined as Cr > 1.2 mg/dl or creatinine clearance less than 50 which is found by doing a blood test
• Presents (within past 6 months) with a high-risk acute coronary syndrome (e.g., unstable chest pain or a heart attack) or has undergone or is scheduled for open heart surgery within 6 months of implantation.
• Has already undergone a heart catheterization with placement of a heart stent or a balloon procedure on the heart has been done.
• Lives within 60 minutes of a hospital that can treat a patient with a heart attack
• 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:
  • 1. Menopausal for the past year
• 2. Hysterectomy
• 3. Use of effective contraceptive method

Exclusion Criteria

• In the physician’s opinion, the patient will be unable to respond appropriately to alarms because of poor memory, dementia, inability to read or any other condition that affects memory.
• A permanent pacemaker or internal defibrillator is already in place or the patient is scheduled to undergo placement of a pacemaker or internal
• Subject cannot feel the sample devices vibration when placed on top of the skin on the left side of the chest.
• Subject has atrial fibrillation (an irregular heart beat).
• Subject has heart enlargement as determined by their physician.
• Subject has any condition that prevents the implantation of the Guardian System device in the left chest area.
• 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.
• Subject has history of bleeding problems
• 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 a possible life expectancy of less than 1 year
• Subject has clinical conditions such as heart diseases, difficult-to-control blood pressure, difficult-to-control insulin-dependent diabetes or serious prior infections because of their diabetes, etc
• 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 (stomach) bleeding 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.

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