Myocardial IschemiaPhase 3NCT00170014
Precision of the Magnetocardiographer for Data Aquision and Analysis.
A Phase 3 study testing Magnetocardiograph in people with Myocardial Ischemia, run by Mayo Clinic at 1 site in United States.
Trial summary
magnetocardiography has been extensively studied focusing on the possible clinical applications of the device. Evaluating the precision of a device is a prerequisite condition to know what are significant changes and how can these be trusted. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Magnetocardiograph
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Age less than or equal to 45 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reproducibility of Magnetocardiography Measurements Using the Cardiomag Magnetocardiograph System Model 2409 and Its Software for Data Acquisition and Analysis
magnetocardiography has been extensively studied focusing on the possible clinical applications of the device. Evaluating the precision of a device is a prerequisite condition to know what are significant changes and how can these be trusted. A respectable reproducibility study for the MCG measurements is crucial for this new device to be used for clinical applications. In this study, we will focus on a critical portion of the heart cycle assessing for changes in time of the computerized analysis of this phase and comparing the analysis done by two examiners.
Read the detailed description
The studies involving magnetocardiography have almost exclusively focused on evaluating possible clinical applications of the device. Leder et al saw the need for investigating the reproducibility of High Temperature Superconducting (HTS-)MCG measurements. They tested 18 healthy volunteers, stating that assessment of the reproducibility of HTS-MCGs in the normal heart is a prerequisite condition for the definition of significant levels of changes which, for instance, may be observed in serial measurements of patients suffering from acute coronary syndromes. They also pointed out the potentially strong electromagnetic interference inside a hospital, likely to be very different from the noise found in engineering laboratories where the MCGs are originally calibrated and tested. A respectable reproducibility for the MCG measurements is crucial for clinical applications. Leder et al studied the reproducibility of QRS complexes, ST segments, and T waves. They found that the reproducibility of the measurements in the depolarization phase was high, whereas the reproducibility of their repolarization readings was considerably lower. The results led Leder et al to conclude that further technical development was needed to improve signal-to-noise ratio allowing for clinical application of repolarization abnormalities for recognizing Acute Coronary Syndromes. In this study, we will focus on the repolarization phase by assessing the reproducibility of the T wave only. Comparison of scores and results based on computer analyses will provide the basis for our evaluation. Visual interpretations by the two examiners will also be compared.
- Conditions
- Myocardial Ischemia
- Being tested
- Magnetocardiograph
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetocardiographDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective of our study is to evaluate inter-examiner reproducibility in the MCG results retrieved from data acquisition and analysis by two examiners. HTS-MCG measurements will be obtained from healthy AND diseased subjects in an unshielded clinical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- CardioMag Imaging
- Investigators
- Peter A. Smars, M.D. EM, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170014
- Sponsor's protocol ID
- 850-04
- Status last verified
- Feb 2011
- First submitted
- 12 Sep 2005
- Last updated
- 15 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Magnetocardiography Measurements Using the Cardiomag Magnetocardiograph System Model 2409 and Its Software for Data Acquisition and Analysis
- ClinicalTrials.gov ID
- NCT00170014
- Acronym / sponsor ID
- 850-04
- Conditions
- Myocardial Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- CardioMag Imaging
- Study start
- Oct 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
magnetocardiography has been extensively studied focusing on the possible clinical applications of the device. Evaluating the precision of a device is a prerequisite condition to know what are significant changes and how can these be trusted. A respectable reproducibility study for the MCG measurements is crucial for this new device to be used for clinical applications. In this study, we will focus on a critical portion of the heart cycle assessing for changes in time of the computerized analysis of this phase and comparing the analysis done by two examiners.
Detailed description
The studies involving magnetocardiography have almost exclusively focused on evaluating possible clinical applications of the device. Leder et al saw the need for investigating the reproducibility of High Temperature Superconducting (HTS-)MCG measurements. They tested 18 healthy volunteers, stating that assessment of the reproducibility of HTS-MCGs in the normal heart is a prerequisite condition for the definition of significant levels of changes which, for instance, may be observed in serial measurements of patients suffering from acute coronary syndromes. They also pointed out the potentially strong electromagnetic interference inside a hospital, likely to be very different from the noise found in engineering laboratories where the MCGs are originally calibrated and tested. A respectable reproducibility for the MCG measurements is crucial for clinical applications. Leder et al studied the reproducibility of QRS complexes, ST segments, and T waves. They found that the reproducibility of the measurements in the depolarization phase was high, whereas the reproducibility of their repolarization readings was considerably lower. The results led Leder et al to conclude that further technical development was needed to improve signal-to-noise ratio allowing for clinical application of repolarization abnormalities for recognizing Acute Coronary Syndromes. In this study, we will focus on the repolarization phase by assessing the reproducibility of the T wave only. Comparison of scores and results based on computer analyses will provide the basis for our evaluation. Visual interpretations by the two examiners will also be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetocardiograph | Device | – |
Primary outcome
The objective of our study is to evaluate inter-examiner reproducibility in the MCG results retrieved from data acquisition and analysis by two examiners. HTS-MCG measurements will be obtained from healthy AND diseased subjects in an unshielded clinical
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2011.
Related trials for Myocardial Ischemia
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A. Smars, M.D. EM principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnetocardiograph in people with Myocardial Ischemia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective of our study is to evaluate inter-examiner reproducibility in the MCG results retrieved from data acquisition and analysis by two examiners. HTS-MCG measurements will be obtained from healthy AND diseased subjects in an unshielded clinical. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2011.