- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00170027
Safety and Efficacy of MCG for Diagnosing Coronary Heart Disease
Safety and Efficacy of the CMI Magnetocardiograph Model 2409 for Diagnosing Coronary Heart Disease
Study Overview
Detailed Description
The CMI-2409 magnetocardiograph (MCG) is an FDA-approved medical device capable of noninvasive recording of magnetic fields arising from the electrical activity of the heart. This system was developed by CMI for the general purpose of noninvasive, non-contact diagnostics of obstructive coronary artery disease (CAD), and especially of cardiac ischemia. The overall objective of the present study is to demonstrate the efficacy of this MCG device and of the associated MCG method for the detection and diagnosis of ischemia in chest pain patients.
The primary objective is to demonstrate that the diagnostic accuracy of the MCG device and method is equivalent to or better than that of a standard 12-lead ECG for detecting the presence of ischemia in patients presenting with chest pain of unknown etiology. In this study the rest MCG data will be analyzed and compared to the results of a rest ECG.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Primary endpoint will be final clinical diagnosis of ischemia by the primary treating physician. This decision will be based upon evaluation of symptoms, clinical presentation, 12-lead ECG, cardiac enzymes (Troponin I or CKMB).
|
Secondary Outcome Measures
Outcome Measure |
---|
1. Correlation of MCG with anatomic patency and TIMI flow on coronary angiography
|
2. Correlation of MCG with functional and laboratory tests
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter A. Smars, M.D. EM, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Ischemia
-
Recardio, Inc.CompletedAcute Myocardial Infarction | STEMI - ST Elevation Myocardial Infarction | Acute Myocardial IschemiaNetherlands, Hungary, Austria, Poland, Belgium
-
University Hospital "Sestre Milosrdnice"CompletedSTEMI - ST Elevation Myocardial Infarction | Myocardial ReperfusionCroatia
-
University of Roma La SapienzaCompletedRosuvastatin in Preventing Myonecrosis in Elective Percutaneous Coronary Interventions (PCIs) (ROMA)Periprocedural Myocardial NecrosisItaly
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Deutsches Herzzentrum MuenchenCompletedInfarction, MyocardialGermany
-
Lokien van NunenMaquet Cardiovascular; Stichting Toegepaste Wetenschappen (project number 11052)CompletedAcute Myocardial Infarction | Persisting Ischemia | No ReflowNetherlands
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
Tomsk National Research Medical Center of the Russian...CompletedMyocardial Infarction | Myocardial Injury | STEMI | Myocardial NecrosisRussian Federation
-
Foundation IRCCS San Matteo HospitalFondazione Poliambulanza Istituto Ospedaliero; Azienda Ospedaliera Ordine Mauriziano... and other collaboratorsWithdrawnST-elevation Myocardial InfarctionItaly
-
INTEGRIS Baptist Medical CenterCompletedST Elevated Myocardial InfarctionUnited States
Clinical Trials on Magnetocardiograph
-
Mayo ClinicCardioMag ImagingCompletedMyocardial IschemiaUnited States
-
Mayo ClinicCardioMag ImagingCompletedHeart TransplantationUnited States
-
Creavo Medical Technologies LtdCompletedAcute Coronary SyndromeUnited Kingdom
-
Mayo ClinicCardioMag ImagingCompletedMyocardial IschemiaUnited States
-
Creavo Medical Technologies LtdUniversity of CincinnatiTerminatedAcute Coronary SyndromeUnited States
-
Genetesis Inc.TerminatedMyocardial Ischemia | Acute Coronary Syndrome | Coronary Artery StenosisUnited States