Myocardial IschemiaNCT00169975
Efficacy of the CMI Magnetocardiograph in Diagnosing Acute Coronary Syndromes in Patients Presenting With High Risk Unstable Angina.
An observational study of Myocardial Ischemia, run by Mayo Clinic at 1 site in United States.
Trial summary
A magnetocardiograph (MCG) is a device capable of recording of magnetic fields arising from the electrical activity of the heart with traces similar to an electrocardiogram (ECG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Magnetocardiograph
- Type of treatment
- Medical device
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Feb 2008
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: *ACC/AHA Guidelines for Unstable Angina: High Risk (≥1 of the following) History * Accelerating tempo of ischemic symptoms in the last 48 hrs Pain * Prolonged, ongoing (>20 min) rest pain (resistant to treatment) Clinical findings * Pulmonary edema * New / ↑ MR murmur * S3 or new/ ↑ rales * Hypotension, brady -/tachycardia - Age>75y ECG * Angina at rest with transient ST changes >0.05 mV * New (L)BBB * Sustained VT Cardiac Markers * Markedly elevated troponin Patients classified as having high-risk unstable angina at presentation in the ED will be approached for enrollment in the study.
Who may be able to join
- Patients classified as having High Risk Unstable Angina according to the ACCIAHA guidelines.
- Age ≥ 18 years.
Who cannot join
- Hemodynamically unstable patients.
- Patients who just prior to or just after admission exhibit tachycardia with heart rates exceeding 150 bpm.
- Patients with third degree AV Block.
- Patients with pacemakers or internal cardiac defibrillators.
- Patients who cannot lie in a supine position for the MCG examination.
- Patients who refuse entry into the registry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the CMI Magnetocardiograph in Diagnosing Acute Coronary Syndromes in Patients Presenting With High Risk Unstable Angina as Defined by ACC/AHA Guidelines
A magnetocardiograph (MCG) is a device capable of recording of magnetic fields arising from the electrical activity of the heart with traces similar to an electrocardiogram (ECG). This system was developed as a noninvasive, non-contact diagnostics of obstructive coronary artery disease (CAD), and especially of lack of oxygen in the heart as in a heart attack. The overall objective of this study is to demonstrate the efficacy of this MCG device for the detection and diagnosis of lack of oxygen of the heart in patients with chest pain.
Read the detailed description
Coronary Artery Disease is the leading cause of death in the United States. The non invasive detection of Acute Coronary Syndromes (ACS's) remains a clinical challenge. Electrocardiogram (ECG) may only diagnose myocardial infarction in 50 % of the cases. Magnetocardiography is a new and noninvasive method capable of measuring and mapping the magnetic field that is generated during the cardiac cycle. The electric current is affected by ischemic damage, which in turn alters the magnetic field. The magnetic field is not affected by body tissues, unlike the surface current measurements in ECG.
Comparisons: The diagnostic accuracy of the CMI-Magnetocardiograph will be compared to that of the ECG in diagnosing High Risk Unstable Angina.
- 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
MCG and ECG recordings sequentially at the four pre-defined bed positions and watches the real-time magnetocardiogram traces on the computer screen. At each position, nine sensors record MCG data, thus forming a 3 x 3 point grid square with point-to-point separation of 40 mm. The number of cardiac cycles recorded at each position should be adequate for signal averaging. Recording time per position is typically 90 seconds. At the end of 4 sequential recordings, raw, unfiltered MCG data are stored.
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Determine the discriminatory ability of the scores derived from the MCG evaluation to discriminate between patients with versus without a clinical diagnosis of ACS at discharge.
Measured: 1 year
2. Compare the discriminatory ability of scores derived from the MCG, the troponin level, and the ECG results, separately or in combination, to discriminate between patients with without a diagnosis of ACS at discharge.
Measured: 1 year
Secondary outcomes (1)
1. Evaluate the sensitivity of the MCG to detect an ultimate diagnosis of ACS, MI, CHF, or death at 1 month, 6 months, and 1 year following discharge.
Measured: 1 year
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 startAug 2004
- Primary completionFeb 2008
- Study completionFeb 2008
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 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
- NCT00169975
- Sponsor's protocol ID
- 738-04
- Status last verified
- Jul 2011
- First submitted
- 12 Sep 2005
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the CMI Magnetocardiograph in Diagnosing Acute Coronary Syndromes in Patients Presenting With High Risk Unstable Angina as Defined by ACC/AHA Guidelines
- ClinicalTrials.gov ID
- NCT00169975
- Acronym / sponsor ID
- 738-04
- Conditions
- Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- CardioMag Imaging
- Study start
- Aug 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (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.
A magnetocardiograph (MCG) is a device capable of recording of magnetic fields arising from the electrical activity of the heart with traces similar to an electrocardiogram (ECG). This system was developed as a noninvasive, non-contact diagnostics of obstructive coronary artery disease (CAD), and especially of lack of oxygen in the heart as in a heart attack. The overall objective of this study is to demonstrate the efficacy of this MCG device for the detection and diagnosis of lack of oxygen of the heart in patients with chest pain.
Detailed description
Coronary Artery Disease is the leading cause of death in the United States. The non invasive detection of Acute Coronary Syndromes (ACS's) remains a clinical challenge. Electrocardiogram (ECG) may only diagnose myocardial infarction in 50 % of the cases. Magnetocardiography is a new and noninvasive method capable of measuring and mapping the magnetic field that is generated during the cardiac cycle. The electric current is affected by ischemic damage, which in turn alters the magnetic field. The magnetic field is not affected by body tissues, unlike the surface current measurements in ECG.
Comparisons: The diagnostic accuracy of the CMI-Magnetocardiograph will be compared to that of the ECG in diagnosing High Risk Unstable Angina.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- *ACC/AHA Guidelines for Unstable Angina: High Risk (≥1 of the following) History * Accelerating tempo of ischemic symptoms in the last 48 hrs Pain * Prolonged, ongoing (>20 min) rest pain (resistant to treatment) Clinical findings * Pulmonary edema * New / ↑ MR murmur * S3 or new/ ↑ rales * Hypotension, brady -/tachycardia - Age>75y ECG * Angina at rest with transient ST changes >0.05 mV * New (L)BBB * Sustained VT Cardiac Markers * Markedly elevated troponin Patients classified as having high-risk unstable angina at presentation in the ED will be approached for enrollment in the study.
Key inclusion criteria (2 listed)
- Patients classified as having High Risk Unstable Angina according to the ACCIAHA guidelines.
- Age ≥ 18 years.
Key exclusion criteria (6 listed)
- Hemodynamically unstable patients.
- Patients who just prior to or just after admission exhibit tachycardia with heart rates exceeding 150 bpm.
- Patients with third degree AV Block.
- Patients with pacemakers or internal cardiac defibrillators.
- Patients who cannot lie in a supine position for the MCG examination.
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 |
|---|---|---|
| MagnetocardiographMCG and ECG recordings sequentially at the four pre-defined bed positions and watches the real-time magnetocardiogram traces on the computer screen. At each position, nine sensors record MCG data, thus forming a 3 x 3 point grid square with point-to-point separation of 40 mm. The number of cardiac cycles recorded at each position should be adequate for signal averaging. Recording time per position is typically 90 seconds. At the end of 4 sequential recordings, raw, unfiltered MCG data are stored. | Device | – |
Primary outcome
1. Determine the discriminatory ability of the scores derived from the MCG evaluation to discriminate between patients with versus without a clinical diagnosis of ACS at discharge.
Time frame: 1 year
2. Compare the discriminatory ability of scores derived from the MCG, the troponin level, and the ECG results, separately or in combination, to discriminate between patients with without a diagnosis of ACS at discharge.
Time frame: 1 year
1 secondary outcome
1. Evaluate the sensitivity of the MCG to detect an ultimate diagnosis of ACS, MI, CHF, or death at 1 month, 6 months, and 1 year following discharge.
Time frame: 1 year
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 18 Jul 2011.
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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?
An observational study of 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?
The sponsor lists 2 inclusion and 6 exclusion criteria. 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 18 Jul 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.
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?
1. Determine the discriminatory ability of the scores derived from the MCG evaluation to discriminate between patients with versus without a clinical diagnosis of ACS at discharge. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 18 Jul 2011.