AngelMed for Early Recognition and Treatment of STEMI
ALERTS
1 other identifier
interventional
1,020
1 country
95
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2008
Longer than P75 for phase_3
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2008
CompletedFirst Posted
Study publicly available on registry
October 28, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2017
CompletedMarch 14, 2018
March 1, 2018
5.4 years
October 24, 2008
March 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy objective is to determine that the Guardian System reduces the composite of Cardiac or unexplained death, new Q-wave MI and time to door for a confirmed occlusive event at a medical facility >2 hours.
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 symptoms) compared to rate of false positive ER visits in the ALARMS\_OFF group due to symptoms only.
Due to Bayesian statistical analysis, the study data will be analyzed after subject enrollment reaches 600, 900, 1200, etc. With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Secondary Outcomes (5)
- Reduction of the incidence of cardiac death or unexplained death during follow-up - Reduction of the incidence of "New" Q-wave myocardial infarction in one or more distributions during follow-up- Reduction of the time to door for confirmed STEMI.
Due to Bayesian statistical analysis, the study data will be analyzed after subject enrollment reaches 600, 900, 1200, etc With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Secondary Endpoint #2
With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Secondary Endpoint #3
With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Secondary Endpoint #4
With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Secondary Endpoint #5
With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Study Arms (2)
Treatment
EXPERIMENTALThe Treatment arm has alerting enabled in their device during the 6-month randomization period. Treatment arm patients also have alerting enabled in the post-randomization period. Once a patient arrives at the ER, the standard of care triage process for MI is followed and that is outside of the ALERTS Study protocol. With Amendment the Treatment arm was re-defined as an ALARMS\_ON group which included A) Control patients after the randomization period and until database lock (4/1/2014); and, b) Treatment patients both during the randomization period and after the randomization period until database lock (4/1/2014).
Control
OTHERThe Control arm has alerting disabled in their device during the 6-month randomization period. Control arm patients also have alerting enabled in the post-randomization period. Once a patient arrives at the ER, the standard of care triage process for MI is followed and that is outside of the ALERTS Study protocol. With Amendment the Control arm was re-defined as an ALARMS\_OFF group which included A) Control patients during the randomization period when the Guardian did not have alarms enabled.
Interventions
There is no intervention in this study. The device is a diagnostic only.
Eligibility Criteria
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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Angel Medical Systemslead
- Symbios Clinicalcollaborator
Study Sites (95)
Cardiology, P.C.
Birmingham, Alabama, 35211, United States
Heart Center Research/Huntsville Hospital
Huntsville, Alabama, 35801, United States
Banner Heart Hospital
Mesa, Arizona, 85206, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Southwest Heart Group
Tucson, Arizona, 85710, United States
John Muir Clinical Research Center
Concord, California, 94520, United States
California Clinical Research Foundation
Glendale, California, 91204, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Mission Internal Medical Group
Mission Viejo, California, 92691, United States
Orange County Heart Institute and Research Center Hospital
Orange, California, 92868, United States
Huntington Memorial Hospital
Pasadena, California, 91105, 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 D.C., District of Columbia, 20010, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744, United States
Daytona Heart Group
Daytona Beach, Florida, 32114, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
NorthFL/South GA VA Health System
Gainesville, Florida, 32608, United States
Mercy Research Institute
Miami, Florida, 33133, United States
University of Miami
Miami, Florida, 33136, United States
New Phase Clinical Trials
Miami Beach, Florida, 33140, United States
Complete Cardiology Care
New Smyrna Beach, Florida, 32169, United States
East Coast Institute for Research
Saint Augustine, Florida, 32086, United States
Univeristy of South Florida
Tampa, Florida, 33606, United States
Florida Hospital - Pepin Heart Institute
Tampa, Florida, 33613, United States
The Medical Center of Central Georgia
Macon, Georgia, 31201-2102, United States
Northwestern University
Chicago, Illinois, 60611, United States
Advocate Medical Group
Park Ridge, Illinois, 60068, United States
Premier Healthcare
Bloomington, Indiana, 47403, United States
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804, United States
Heart Center of Lake County
Merrillville, Indiana, 46410, United States
Medical Consultants, PC
Muncie, Indiana, 47303, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Innovative Medical Research
Covington, Louisiana, 70433, United States
Heart Clinic of Hammond
Hammond, Louisiana, 70403, United States
Louisiana Heart Center
Slidell, Louisiana, 70433, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
MedStar Health Research Institute
Baltimore, Maryland, 21239, United States
Suburban Hospital - Johns Hopkins Medicine
Bethesda, Maryland, 20814, United States
Woodholme Cardiovacular Associates
Pikesville, Maryland, 21208, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
McLaren Bay Region
Bay City, Michigan, 48708, United States
DMC Cardiovascular Institute at Harper-Hutzel Hospital
Detroit, Michigan, 48201, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334, United States
Cardiology Consultants of East Michigan
Flint, Michigan, 48532, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
McLaren Macomb
Mount Clemens, Michigan, 48043, United States
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754, United States
University of Medicine & Dentistry NJ
New Brunswick, New Jersey, 08901, United States
St. Michael's Medical Center
Newark, New Jersey, 07102, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043, United States
Albany Associates in Cardiology
Albany, New York, 12205, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Buffalo Heart Group - Mercy Hospital of Buffalo
Buffalo, New York, 14215, United States
Buffalo Heart Group - Millard Fillmore Gates Circle Hospital
Buffalo, New York, 14215, United States
Columbia University Medical Center
New York, New York, 10032, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Cardiology Group of Western New York
Williamsville, New York, 14221, 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
University of Toledo
Toledo, Ohio, 43614, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
St. Mary Medical Center Research Institute
Langhorne, Pennsylvania, 19047, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
Donald Guthrie Foundation for Education & Research
Sayre, Pennsylvania, 18840, United States
Geisinger Wyoming Valley Heart Hospital
Wilkes-Barre, Pennsylvania, 18711, United States
Cardiac Diagnostic Associates/York Hospital
York, Pennsylvania, 17405, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
Stern Cardiovascular Center
Germantown, Tennessee, 38138, United States
Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
St. Thomas Research Institute
Nashville, Tennessee, 37203, United States
Cardiology Center of Amarillo
Amarillo, Texas, 79106, United States
West Houston Area Clinical Trial Consultants
Houston, Texas, 77008, United States
West Houston Area Clinical Trial Consultants
Houston, Texas, 77094, United States
Scott and White Healthcare
Temple, Texas, 76502, United States
Tyler Cardiovascular Consultants
Tyler, Texas, 75701, United States
Cardiology Associates of Fredericksburg
Fredericksburg, Virginia, 22408, United States
Virginia Cardiovascular Associates
Manassas, Virginia, 20109, United States
Riverside Regional Medical Center
Newport News, Virginia, 23601, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507, United States
Cardiovascular Associates, Ltd
Virginia Beach, Virginia, 23462, United States
Swedish Medical Center/Cardiovascular Research
Seattle, Washington, 98122, United States
Related Publications (4)
Holmes DR Jr, Krucoff MW, Mullin C, Mikdadi G, Presser D, Wohns D, Kaplan A, Ciuffo A, Eberly AL 3rd, Iteld B, Fischell DR, Fischell T, Keenan D, John MS, Gibson CM. Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events. J Am Coll Cardiol. 2019 Oct 22;74(16):2047-2055. doi: 10.1016/j.jacc.2019.07.084.
PMID: 31623762DERIVEDGibson CM, Holmes D, Mikdadi G, Presser D, Wohns D, Yee MK, Kaplan A, Ciuffo A, Eberly AL 3rd, Iteld B, Krucoff MW. Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2019 Apr 23;73(15):1919-1927. doi: 10.1016/j.jacc.2019.01.014. Epub 2019 Mar 3.
PMID: 30842028DERIVEDRogers T, Steinvil A, Torguson R, Waksman R. Overview of the 2016 US Food and Drug Administration Circulatory System Devices Panel Meeting on the AngelMed Guardian System. Circulation. 2016 Jul 19;134(3):262-4. doi: 10.1161/CIRCULATIONAHA.116.023081. No abstract available.
PMID: 27436882DERIVEDGibson MC, Krucoff M, Fischell D, Fischell TA, Keenan D, Abueg C, Patel C, Holmes D. Rationale and design of the AngeLmed for Early Recognition and Treatment of STEMI trial: a randomized, prospective clinical investigation. Am Heart J. 2014 Aug;168(2):168-74. doi: 10.1016/j.ahj.2014.05.008. Epub 2014 May 24.
PMID: 25066555DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2008
First Posted
October 28, 2008
Study Start
December 1, 2008
Primary Completion
May 1, 2014
Study Completion
May 17, 2017
Last Updated
March 14, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share
When we have completed review with the FDA, the IPD will will be made available.