AngelMed for Early Recognition and Treatment of STEMI (ALERTS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Symbios Clinical
Information provided by (Responsible Party):
Angel Medical Systems
ClinicalTrials.gov Identifier:
NCT00781118
First received: October 24, 2008
Last updated: November 1, 2013
Last verified: July 2013
  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.


Condition Intervention Phase
Acute Myocardial Infarction (AMI)
Coronary Occlusion
Acute Coronary Syndrome
Device: AngelMed Guardian System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: AngelMed for Early Recognition and Treatment of STEMI

Resource links provided by NLM:


Further study details as provided by Angel Medical Systems:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • The primary safety objective is to demonstrate that the proportion of implanted subjects who are free from system-related complications at six months post programming is at least 90%. [ Time Frame: Due to Bayesian statistical analysis, the study data will be analyzed after subject enrollment reaches 600, 900, 1200, etc. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • - 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1020
Study Start Date: December 2008
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Alerting will be turned "ON" during Initial Programming at 7-14 Day visit. Subjects will be trained on the use of the Guardian System at the 7-14 Day Visit and be provided refresher courses at subsequent follow-up visits.
Device: AngelMed Guardian System
An implantable heart monitoring device that detects and alerts subjects to rapidly progressive ST shifts that might be indicative of thrombotic coronary occlusions. Components include Programmable monitoring device (IMD), Right Ventricle Lead, Lead Adapter, External Alarm Device (EXD) and a programmer.
Control
Subjects will receive standard of care. From the 7-14 Day Visit through 6 month follow-up visit alerting will be turned "OFF". At initial 6 month follow-up visit alerting will be turned "ON" and subjects will be trained on the use of the Guardian System.
Device: AngelMed Guardian System
An implantable heart monitoring device that detects and alerts subjects to rapidly progressive ST shifts that might be indicative of thrombotic coronary occlusions. Components include Programmable monitoring device (IMD), Right Ventricle Lead, Lead Adapter, External Alarm Device (EXD) and a programmer.

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.1,4,7

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781118

  Show 95 Study Locations
Sponsors and Collaborators
Angel Medical Systems
Symbios Clinical
  More Information

No publications provided

Responsible Party: Angel Medical Systems
ClinicalTrials.gov Identifier: NCT00781118     History of Changes
Other Study ID Numbers: ALERTS Study
Study First Received: October 24, 2008
Last Updated: November 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Angel Medical Systems:
Acute Myocardial Infarction (MI)
ST Shift
Coronary Occlusion
Acute Coronary Syndrome

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Coronary Occlusion
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014