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Trial record 3 of 8 for:    cardioflux

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

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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.

Tracking Information
First Submitted Date August 17, 2017
First Posted Date August 21, 2017
Last Update Posted Date August 31, 2018
Actual Study Start Date July 15, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 17, 2017)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients
Official Title Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Acute Coronary Syndrome
  • Myocardial Infarction
Intervention 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
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: Magnetocardiography
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 29, 2018)
101
Original Estimated Enrollment
 (submitted: August 17, 2017)
100
Actual Study Completion Date May 1, 2018
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03255772
Other Study ID Numbers 1053362-5
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: No
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.
Responsible Party Genetesis Inc.
Study Sponsor Genetesis Inc.
Collaborators St. John Hospital & Medical Center
Investigators Not Provided
PRS Account Genetesis Inc.
Verification Date August 2018