Acute Myocardial Infarction (AMI)Phase 3ALERTSNCT00781118
AngelMed for Early Recognition and Treatment of STEMI
A Phase 3 study testing Guardian System in people with Acute Myocardial Infarction (AMI) and Coronary Occlusion, run by Angel Medical Systems at 95 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI), Coronary Occlusion, Acute Coronary Syndrome
- What is being tested?
- Guardian System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 95 sitesUnited States
- Study dates
- Dec 2008to 17 May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
95 sites in 1 country.
95 sites in 1 country
United States95 sites
Albany Associates in Cardiology
Albany, New York, 12205
Cardiology Center of Amarillo
Amarillo, Texas, 79106
AnMed Health
Anderson, South Carolina, 29621
University of Maryland Medical Center
Baltimore, Maryland, 21201
MedStar Health Research Institute
Baltimore, Maryland, 21239
McLaren Bay Region
Bay City, Michigan, 48708
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
Suburban Hospital - Johns Hopkins Medicine
Bethesda, Maryland, 20814
Cardiology, P.C.
Birmingham, Alabama, 35211
Premier Healthcare
Bloomington, Indiana, 47403
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Buffalo Heart Group - Mercy Hospital of Buffalo
Buffalo, New York, 14215
Buffalo Heart Group - Millard Fillmore Gates Circle Hospital
Buffalo, New York, 14215
Northwestern University
Chicago, Illinois, 60611
John Muir Clinical Research Center
Concord, California, 94520
Innovative Medical Research
Covington, Louisiana, 70433
Geisinger Medical Center
Danville, Pennsylvania, 17822
Good Samaritan Hospital
Dayton, Ohio, 45406
Daytona Heart Group
Daytona Beach, Florida, 32114
DMC Cardiovascular Institute at Harper-Hutzel Hospital
Detroit, Michigan, 48201
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334
Cardiology Consultants of East Michigan
Flint, Michigan, 48532
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804
Cardiology Associates of Fredericksburg
Fredericksburg, Virginia, 22408
NorthFL/South GA VA Health System
Gainesville, Florida, 32608
Stern Cardiovascular Center
Germantown, Tennessee, 38138
California Clinical Research Foundation
Glendale, California, 91204
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
Spectrum Health
Grand Rapids, Michigan, 49503
Greenville Hospital System
Greenville, South Carolina, 29605
Heart Clinic of Hammond
Hammond, Louisiana, 70403
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
West Houston Area Clinical Trial Consultants
Houston, Texas, 77008
West Houston Area Clinical Trial Consultants
Houston, Texas, 77094
Heart Center Research/Huntsville Hospital
Huntsville, Alabama, 35801
Borgess Medical Center
Kalamazoo, Michigan, 49048
Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
St. Mary Medical Center Research Institute
Langhorne, Pennsylvania, 19047
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Central Baptist Hospital
Lexington, Kentucky, 40503
Long Beach Memorial Medical Center
Long Beach, California, 90806
The Medical Center of Central Georgia
Macon, Georgia, 31201-2102
Virginia Cardiovascular Associates
Manassas, Virginia, 20109
Heart Center of Lake County
Merrillville, Indiana, 46410
Banner Heart Hospital
Mesa, Arizona, 85206
Mercy Research Institute
Miami, Florida, 33133
University of Miami
Miami, Florida, 33136
New Phase Clinical Trials
Miami Beach, Florida, 33140
Mission Internal Medical Group
Mission Viejo, California, 92691
McLaren Macomb
Mount Clemens, Michigan, 48043
Medical Consultants, PC
Muncie, Indiana, 47303
St. Thomas Research Institute
Nashville, Tennessee, 37203
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754
University of Medicine & Dentistry NJ
New Brunswick, New Jersey, 08901
Complete Cardiology Care
New Smyrna Beach, Florida, 32169
Columbia University Medical Center
New York, New York, 10032
St. Michael's Medical Center
Newark, New Jersey, 07102
Riverside Regional Medical Center
Newport News, Virginia, 23601
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135
Orange County Heart Institute and Research Center Hospital
Orange, California, 92868
Advocate Medical Group
Park Ridge, Illinois, 60068
Huntington Memorial Hospital
Pasadena, California, 91105
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
Woodholme Cardiovacular Associates
Pikesville, Maryland, 21208
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
REX Healthcare
Raleigh, North Carolina, 27607
Mayo Clinic
Rochester, Minnesota, 55905
University of California Davis Medical Center
Sacramento, California, 95817
Sutter Memorial Hospital
Sacramento, California, 95819
East Coast Institute for Research
Saint Augustine, Florida, 32086
Salinas Valley Memorial Hospital
Salinas, California, 93901
Radiant Research
Santa Rosa, California, 95405
Donald Guthrie Foundation for Education & Research
Sayre, Pennsylvania, 18840
Swedish Medical Center/Cardiovascular Research
Seattle, Washington, 98122
Louisiana Heart Center
Slidell, Louisiana, 70433
Stony Brook University Medical Center
Stony Brook, New York, 11794
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Univeristy of South Florida
Tampa, Florida, 33606
Florida Hospital - Pepin Heart Institute
Tampa, Florida, 33613
Scott and White Healthcare
Temple, Texas, 76502
Cardiovascular Research Center
Toledo, Ohio, 43608
University of Toledo
Toledo, Ohio, 43614
Southwest Heart Group
Tucson, Arizona, 85710
Tyler Cardiovascular Consultants
Tyler, Texas, 75701
Cardiovascular Associates, Ltd
Virginia Beach, Virginia, 23462
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Geisinger Wyoming Valley Heart Hospital
Wilkes-Barre, Pennsylvania, 18711
Cardiology Group of Western New York
Williamsville, New York, 14221
Cardiac Diagnostic Associates/York Hospital
York, Pennsylvania, 17405
About this study
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.
Read the detailed description
There are over one million acute myocardial infarctions (AMI) each year in the United States with more than 400,000 of these resulting in death. Early identification of AMI, and prompt treatment has been shown to significantly improve clinical outcomes. Experimental and clinical studies have shown that most of the irreversible damage to the myocardium occurs during the first two hours after coronary occlusion. Milavetz et al. demonstrated that successful reperfusion therapy within two hours was associated with the greatest degree of myocardial salvage. According to Boersma, et al., restoration of flow, regardless of the method used, can abort infarction within the first 30 minutes after coronary occlusion, and the benefit of fibrinolytic therapy compared with placebo is considerably higher in patients treated within 2 hours after symptom onset than in those treated later.2 Further, evidence exists that expeditious restoration of flow in the obstructed infarct artery after the onset of symptoms in patients with the most severe type of MI, ST elevation MI (STEMI) is a key determinant of short and long-term outcomes regardless of whether reperfusion is accomplished by fibrinolysis or percutaneous coronary intervention (PCI). Therefore, the early arrival at the hospital for a reliable diagnosis and initiation of treatment is paramount to improve the outcomes of myocardial infarction. However, despite efforts at educating the public over the past decade, the mean time from AMI symptom onset to arrival at a hospital for treatment has remained, disappointingly, at 2.5-3.0 hours.
The largest proportion of the total pre-hospital delay is the interval between the onset of symptoms and the decision to seek medical treatment. Finnegan et al. described that the reasons for delay in seeking medical evaluation generally stem from patient misconceptions about symptom experience, expectations, and attribution. In many cases, 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 would take action during the first hour following symptom onset, many lives and significant cost could be saved. It is technically possible to monitor EKGs and detect an acute infarction, even if the patient is unaware that he or she is experiencing a heart attack. However, currently available systems have limitations in the home environment. Twelve lead EKG systems require a clinically trained individual to place them. Holter monitors suffer from limitations in the ability to detect ST deviation due to low compliance and are limited in practice to 24 to 72 hours of monitoring. Systems using surface leads are all subject to noise and other artifacts from patient movement and body orientation, particularly if the patient is ambulatory.
A potentially ideal solution is to implant a device that measures heart signals from inside the heart and will alert the patient when it detects electrogram characteristics set by the physician as worthy of medical evaluation.
- Being tested
- Guardian System
- Keywords
- Acute Myocardial Infarction (MI), ST Shift, Coronary Occlusion, Acute Coronary Syndrome
- Medical subject headings
- Coronary Occlusion, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardian SystemDevice
There is no intervention in this study. The device is a diagnostic only.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The 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). Receives: Device: Guardian System |
| Control | Other | The 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. Receives: Device: Guardian System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
With Amendment the secondary efficacy endpoint measures were amended to include Endpoint #1) a hypothesis test of superiority 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.
Measured: 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 secondary efficacy endpoint measures were amended to include Endpoint #2) The number of Silent MIs, the percentage in relation to total MIs in the ALARMS ON group, and the percentage of subjects experiencing Silent MIs will be reported (no hypotheses existed for this endpoint)
Measured: With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Secondary Endpoint #3
With Amendment the secondary efficacy endpoint measures were amended to include Endpoint #3) Descriptive statistics for the median, average and distribution of symptom-to-door and alarm-to-door times for STEMI events and the number and percentage of subjects with time-to-door times of < 2 hours will be reported for both the ALARMS ON and ALARMS OFF groups (no hypotheses existed for this endpoint).
Measured: With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Secondary Endpoint #4
With Amendment the secondary efficacy endpoint measures were amended to include Endpoint #4) The time that elapses between the initial patient prompt (alarm or symptom) and arrival at a medical facility will be calculated for all subjects who suffered a STEMI or NSTEMI, and had an associated Guardian alarm (no hypotheses existed for this endpoint).
Measured: With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Secondary Endpoint #5
With Amendment the secondary efficacy endpoint measures were amended to include Endpoint #5: The time that elapses between the initial patient prompt (Alarm or Symptom) and arrival at a medical facility will be calculated for all subjects who suffered an ACS event (STEMI, NSTEMI, or Unstable Angina), and had an associated Guardian System alarm (with or without symptoms) (no hypotheses existed for this endpoint).
Measured: With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startDec 2008
- Primary completion1 May 2014
- Study completion17 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angel Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symbios Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781118
- Sponsor's protocol ID
- ALERTS Study
- Acronym
- ALERTS
- Status last verified
- Mar 2018
- First submitted
- 24 Oct 2008
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: When we have completed review with the FDA, the IPD will will be made available.
Publications
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.
PubMed 31623762Gibson 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.
PubMed 30842028Rogers 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.
PubMed 27436882Gibson 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.
PubMed 25066555
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AngelMed for Early Recognition and Treatment of STEMI
- ClinicalTrials.gov ID
- NCT00781118
- Acronym / sponsor ID
- ALERTS / ALERTS Study
- Keywords
- Acute Myocardial Infarction (MI), ST Shift, Coronary Occlusion, Acute Coronary Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (actual)
- Lead sponsor
- Angel Medical SystemsIndustry (pharma, biotech, devices)
- Collaborators
- Symbios Clinical
- Study start
- Dec 2008 (actual)
- Primary completion
- 1 May 2014 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 28 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are over one million acute myocardial infarctions (AMI) each year in the United States with more than 400,000 of these resulting in death. Early identification of AMI, and prompt treatment has been shown to significantly improve clinical outcomes. Experimental and clinical studies have shown that most of the irreversible damage to the myocardium occurs during the first two hours after coronary occlusion. Milavetz et al. demonstrated that successful reperfusion therapy within two hours was associated with the greatest degree of myocardial salvage. According to Boersma, et al., restoration of flow, regardless of the method used, can abort infarction within the first 30 minutes after coronary occlusion, and the benefit of fibrinolytic therapy compared with placebo is considerably higher in patients treated within 2 hours after symptom onset than in those treated later.2 Further, evidence exists that expeditious restoration of flow in the obstructed infarct artery after the onset of symptoms in patients with the most severe type of MI, ST elevation MI (STEMI) is a key determinant of short and long-term outcomes regardless of whether reperfusion is accomplished by fibrinolysis or percutaneous coronary intervention (PCI). Therefore, the early arrival at the hospital for a reliable diagnosis and initiation of treatment is paramount to improve the outcomes of myocardial infarction. However, despite efforts at educating the public over the past decade, the mean time from AMI symptom onset to arrival at a hospital for treatment has remained, disappointingly, at 2.5-3.0 hours.
The largest proportion of the total pre-hospital delay is the interval between the onset of symptoms and the decision to seek medical treatment. Finnegan et al. described that the reasons for delay in seeking medical evaluation generally stem from patient misconceptions about symptom experience, expectations, and attribution. In many cases, 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 would take action during the first hour following symptom onset, many lives and significant cost could be saved. It is technically possible to monitor EKGs and detect an acute infarction, even if the patient is unaware that he or she is experiencing a heart attack. However, currently available systems have limitations in the home environment. Twelve lead EKG systems require a clinically trained individual to place them. Holter monitors suffer from limitations in the ability to detect ST deviation due to low compliance and are limited in practice to 24 to 72 hours of monitoring. Systems using surface leads are all subject to noise and other artifacts from patient movement and body orientation, particularly if the patient is ambulatory.
A potentially ideal solution is to implant a device that measures heart signals from inside the heart and will alert the patient when it detects electrogram characteristics set by the physician as worthy of medical evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Guardian SystemThe 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 | Other | Device: Guardian SystemThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject has at least one of the following conditions:
- 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:
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guardian SystemThere is no intervention in this study. The device is a diagnostic only. | Device | Control, Treatment |
Primary outcome
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.
Time frame: 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.
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.
5 secondary outcomes
- 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.
Time frame: 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
Time frame: With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Secondary Endpoint #3
Time frame: With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Secondary Endpoint #4
Time frame: With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Secondary Endpoint #5
Time frame: With amendment the study period spanned from December 2008 until database lock April 1, 2014.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Derived from this study: PubMed 31623762Holmes 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.
- Derived from this study: PubMed 30842028Gibson 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.
- Derived from this study: PubMed 27436882Rogers 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.
- Derived from this study: PubMed 25066555Gibson 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.
- Individual participant dataSharing planned: Yes. When we have completed review with the FDA, the IPD will will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
95 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Guardian System in people with Acute Myocardial Infarction (AMI) and Coronary Occlusion, run by Angel Medical Systems at 95 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00781118, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.