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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in United States

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 groups in NCT00781118
Study groupRoleWhat they receive
TreatmentExperimentalThe 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
ControlOtherThe 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.

  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.

    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)

  1. - 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  1. First posted28 Oct 2008 (estimated)
  2. Study startDec 2008
  3. Primary completion1 May 2014
  4. Study completion17 May 2017

Resources

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)
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 31623762

  • Gibson 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 30842028

  • Rogers 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 27436882

  • Gibson 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

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.

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