Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    genetesis
Previous Study | Return to List | Next Study

Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03255772
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
St. John Hospital & Medical Center
Information provided by (Responsible Party):
Genetesis Inc.

Brief Summary:

Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG) analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the Cardioflux system will be compared with stress testing methods as well as the results of cardiac catheterization to identify patients with myocardial ischemia.

This is a prospective observational single-blinded convenience pilot study of 100 patients placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital and Medical Center (Detroit, MI).

Patients enrolled in the study will also have a 30 and 180 day follow up for analysis of adverse cardiac events.


Condition or disease Intervention/treatment
Acute Coronary Syndrome Myocardial Infarction Diagnostic Test: Magnetocardiography

Layout table for study information
Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients
Actual Study Start Date : July 15, 2017
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Group/Cohort Intervention/treatment
Acute Chest pain
All patients admitted to the Clinical Decision Unit presenting to the Emergency Department (ED) with chest pain with risk factors suggesting a possible cardiac etiology.
Diagnostic Test: Magnetocardiography
Study subjects will be placed within a magnetic shielding apparatus. Noninvasive sensors placed over the subject's torso will acquire magnetic field fluctuations generated by cardiac activity, which will then be analyzed for evidence of myocardial ischemia.
Other Name: Cardioflux Scan




Primary Outcome Measures :
  1. Identification of Active Myocardial Ischemia [ Time Frame: 2 days ]
    Comparison of Magnetocardiography (MCG) and imaging of myocardial magnetic field/current will be performed directly with standard stress testing protocols performed on patients admitted to a cardiac observation unit.

  2. Identification of Active Myocardial Ischemia [ Time Frame: 1 week ]
    Comparison of Magnetocardiography (MCG) and imaging of magnetic field/current will be directly compared to cardiac catheterization data in those patients who undergo this procedure.


Secondary Outcome Measures :
  1. Medium term Adverse Cardiac Events [ Time Frame: 6 months ]
    In patients discharged from the cardiac observation unit with a negative stress test result, how does MCG results correlate with major adverse cardiac events (MACE) at 30 days and 6 months following discharge? MACE will be defined as acute myocardial infarction, coronary revascularization, and all-cause death.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Investigators are conducting a prospective observational double-blinded convenience pilot study of 100 patients over the age of 18 years that are to be placed in the CDU for evaluation of chest pain. Patients selected for this study will be screened using the stated eligibility criteria. Estimated time frame of patient enrollment is 3 - 6 months.

Patients who are to be placed in the CDU for evaluation of chest pain of possible cardiac origin will be eligible for the MCG-CF scan based on above criteria.

Criteria

Inclusion Criteria: Low and intermediate risk ED patients presenting with chest pain of possible cardiac origin who have a negative first troponin result and non-diagnostic ECG that are to be placed in the Cardiac Diagnostic Unit (CDU) for further evaluation.

Exclusion Criteria:

  1. 18 years of age
  2. Patients unable to fit into device
  3. Non-ambulatory patients
  4. Positive response on MCG Pre-Screening Form (for implanted metallic objects)
  5. Atrial fibrillation (AF) with rapid ventricular response (RVR)
  6. Patients with claustrophobia or unable to lie supine for 2 minutes
  7. Pregnant women
  8. Poor candidate for follow-up (e.g. no access to phone)
  9. Prisoners
  10. Repeat participants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255772


Locations
Layout table for location information
United States, Michigan
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Sponsors and Collaborators
Genetesis Inc.
St. John Hospital & Medical Center

Publications:
Brindis RG, Douglas PS, Hendel RC, Peterson ED, Wolk MJ, Allen JM, Patel MR, Raskin IE, Hendel RC, Bateman TM, Cerqueira MD, Gibbons RJ, Gillam LD, Gillespie JA, Hendel RC, Iskandrian AE, Jerome SD, Krumholz HM, Messer JV, Spertus JA, Stowers SA; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American Society of Nuclear Cardiology; American Heart Association. ACCF/ASNC appropriateness criteria for single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI): a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group and the American Society of Nuclear Cardiology endorsed by the American Heart Association. J Am Coll Cardiol. 2005 Oct 18;46(8):1587-605. Review. Erratum in: J Am Coll Cardiol. 2005 Dec 6;46(11):2148-50.

Layout table for additonal information
Responsible Party: Genetesis Inc.
ClinicalTrials.gov Identifier: NCT03255772     History of Changes
Other Study ID Numbers: 1053362-5
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All patient data will be redacted in terms of name, date of birth and identifying medical record numbers. Patients with specific clinical characteristics may be shared with other researchers if the current protocol is expanded to additional sites or continued within the same research site.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Genetesis Inc.:
Magnetocardiography
Chest pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Acute Coronary Syndrome
Infarction
Emergencies
Chest Pain
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Disease Attributes
Pain
Neurologic Manifestations
Signs and Symptoms