FREE TREATMENT REPORT

See ratings and reviews when you sign up for an account.

AngelMed for Early Recognition and Treatment of STEMI

This study is currently Recruiting

May 2011 By Angel Medical Systems

First Recieved on October 24, 2008

Last Updated on May 6, 2011

Sponsor: Angel Medical Systems
Collaborators: Symbios Clinical
Information provided by: Angel Medical Systems
Identifier: NCT00781118

Purpose

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Eligibility

Ages Eligible for Study:21 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Subject has at least one of the following conditions: 1. Diabetes (Type I or Type II) 2. Compromised renal function (Cr > 1.2 mg/dl or creatinine clearance less than 50) 3. 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: 1. Post-menopause or amenorrheic during the past year 2. Surgical sterilization 3. Use of effective contraceptive method Exclusion Criteria: - 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.

Investigators

Locations

  • Princeton Baptist Health System

    Birmingham, Alabama 35211 United States

  • Huntsville Hospital/Heart CTR Research

    Huntsville, Alabama 35801 United States

  • Banner Heart Hospital

    Mesa, Arizona 85206 United States

  • Banner Good Samaritan Hospital

    Phoenix, Arizona 85006 United States

  • Long Beach Memorial Medical Center

    Long Beach, California 90806 United States

  • Orange County Heart Institute and Research Center Hospital

    Orange, California 92868 United States

  • University of California Davis Medical Center

    Sacramento, California 95817 United States

  • Sutter Memorial Hospital

    Sacramento, California 95819 United States

  • Salinas Valley Memorial Hospital

    Salinas, California 93901 United States

  • Radiant Research

    Santa Rosa, California 95405 United States

  • Washington Hospital Center

    Washington, District of Columbia 20010 United States

  • Holy Cross Hospital

    Fort Lauderdale, Florida 33308 United States

  • NorthFL/South GA VA Health System

    Gainesville, Florida 32608 United States

  • Univeristy of South Florida

    Tampa, Florida 33606 United States

  • The Medical Center of Georgia

    Macon, Georgia 31201-2102 United States

  • Northwestern University

    Chicago, Illinois 60611 United States

  • Advocate Medical

    Park Ridge, Illinois 60068 United States

  • Prairie Education Research Cooperative

    Springfield, Illinois 62701 United States

  • Northern Indiana Research Alliance

    Fort Wayne, Indiana 46804 United States

  • Innovative Medical Research

    Mandeville, Louisiana 70433 United States

  • Louisiana Heart Center

    Slidell, Louisiana 70458 United States

  • University of Maryland Medical Center

    Baltimore, Maryland 21157 United States

  • Washington Adventist Hospital

    Tacoma Park, Maryland 20912 United States

  • DMC Cardiovascular Institute at Harper-Hutzel Hospital

    Detroit, Michigan 48201 United States

  • Cardiology Consultants of East Michigan

    Flint, Michigan 48532 United States

  • Spectrum Health

    Grand Rapids, Michigan 49503 United States

  • Borgess Heart Institute

    Kalamazoo, Michigan 49048 United States

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07754 United States

  • REX Healthcare

    Raleigh, North Carolina 27607 United States

  • Good Samaritan Hospital

    Dayton, Ohio 45406 United States

  • Cardiovascular Research Center

    Toledo, Ohio 43608 United States

  • Geisinger Medical Center

    Danville, Pennsylvania 17822 United States

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania 17033 United States

  • Cardiac Diagnostic Associates/York Hospital

    York, Pennsylvania 17403 United States

  • Stern Cardiovascular Center

    Germantown, Tennessee 38138 United States

  • Mercy Medical Center West

    Knoxville, Tennessee 37934 United States

  • Riverside Regional Medical Center

    Newport News, Virginia 23601 United States

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia 23507 United States

  • Swedish Medical Center

    Seattle, Washington 98122 United States

advertisement
V2012.311.925.327
Disclaimer: The list and ratings above are for informational purposes only, and is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. The goal of the information is to provide you with a comprehensive view of all available treatments, but should not be construed to indicate that use of any one treatment is safe, appropriate, or effective for you. Decisions about use of a new treatment, or about a change in your current treatment plan, should be in consultation with your doctor or other healthcare professional.