Back to resultsMCG Discovery Study in Emergency Departments
Primary Purpose
ACS - Acute Coronary Syndrome, NSTEMI - Non-ST Segment Elevation MI
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sponsor MCG device
Sponsored by
About this trial
This is an interventional device feasibility trial for ACS - Acute Coronary Syndrome focused on measuring magnetocardiography, MCG
Eligibility Criteria
Inclusion Criteria: Presents to ED with symptoms of Acute Coronary Syndrome (ACS) Can provide written consent Exclusion Criteria: Presents to ED with ST-Elevation Myocardial Infarction (STEMI) Presents to ED with Atrial Fibrillation Clear non-ischemic cause for symptoms (i.e. trauma) Active thoracic metal implants
Sites / Locations
- Icahn School of Medicine at Mount SinaiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sponsor MCG device
Arm Description
All participants will receive a scan from the Sponsor MCG device
Outcomes
Primary Outcome Measures
% analyzable Sandbox MCG data
% Sandbox MCG data collected and suitable for analysis
Secondary Outcome Measures
Sandbox MCG safety
Device-related adverse events
Characterization of scan results that may differentiate between high risk and low risk ACS patients
Signal Noise Ratio of ECG features
Characterization of scan results that may differentiate between high risk and low risk ACS patients
t-wave field maximum angle
Characterization of scan results that may differentiate between high risk and low risk ACS patients
heartbeats needed to obtain signal
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06095557
Brief Title
MCG Discovery Study in Emergency Departments
Official Title
Discovery Study of Using a Magnetocardiography (MCG) Device at Emergency Departments (EDs)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SB Technology, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile MCG device in an Emergency Department (ED) setting. The main question it aims to answer is whether interpretable data can be reliably collected as part of an ED workflow.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACS - Acute Coronary Syndrome, NSTEMI - Non-ST Segment Elevation MI
Keywords
magnetocardiography, MCG
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sponsor MCG device
Arm Type
Experimental
Arm Description
All participants will receive a scan from the Sponsor MCG device
Intervention Type
Device
Intervention Name(s)
Sponsor MCG device
Intervention Description
unshielded device measuring cardiac magnetic fields
Primary Outcome Measure Information:
Title
% analyzable Sandbox MCG data
Description
% Sandbox MCG data collected and suitable for analysis
Time Frame
during the procedure (MCG scan)
Secondary Outcome Measure Information:
Title
Sandbox MCG safety
Description
Device-related adverse events
Time Frame
30 days
Title
Characterization of scan results that may differentiate between high risk and low risk ACS patients
Description
Signal Noise Ratio of ECG features
Time Frame
during the procedure (MCG scan)
Title
Characterization of scan results that may differentiate between high risk and low risk ACS patients
Description
t-wave field maximum angle
Time Frame
during the procedure (MCG scan)
Title
Characterization of scan results that may differentiate between high risk and low risk ACS patients
Description
heartbeats needed to obtain signal
Time Frame
during the procedure (MCG scan)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presents to ED with symptoms of Acute Coronary Syndrome (ACS)
Can provide written consent
Exclusion Criteria:
Presents to ED with ST-Elevation Myocardial Infarction (STEMI)
Presents to ED with Atrial Fibrillation
Clear non-ischemic cause for symptoms (i.e. trauma)
Active thoracic metal implants
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frances Lu
Phone
650-722-8682
Email
clinical-trials@sandboxquantum.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kit Yee Au-Yeung, PhD
Organizational Affiliation
SB Technology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sajiny John
Phone
631-750-6345
Email
sajiny.john@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Bander, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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MCG Discovery Study in Emergency Departments
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