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Hypertrophic CardiomyopathyNCT00574821

Use of Magnetic Field Mapping in the Evaluation of Patients With Hypertrophic Heart Disease (Thick Heart Muscle)

An observational study of Hypertrophic Cardiomyopathy, run by Cedars-Sinai Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this research study is to further establish the diagnostic use of magnetocardiography (MCG) in patients with hypertrophic cardiomyopathy (HCM). The use of MCG has not been extensively studied in these patients. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Hypertrophic Cardiomyopathy
How many people
20 participants
Where
1 siteUnited States
Study dates
Jul 2007to Dec 2009
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: We will enroll a total of twenty patients identified to have hypertrophic cardiomyopathy.

Who may be able to join

  • Any patient that is hemodynamically stable and is identified to have hypertrophic cardiomyopathy based on prior symptoms, 2D ECHO findings, genetic testing, and/or ECG voltage criteria.
  • Patients that have signed informed consent after understanding the risks and benefits of participation. Individual age 16-17 with the consent and approval of a parent and /or legal guardian.

Who cannot join

  • Patients with prior history of myocardial infarction, CAD demonstrated by stress test or angiogram, and/or CABG will be excluded from this study.
  • Any patient that has undergone invasive treatment at the time of enrollment including procedures such as myomectomy and/or septal ablation. However, already enrolled subjects who have these procedures post-enrollment into the study will be eligible for future scans.
  • Patients encountering any significant symptoms, chest pain, or who are hemodynamically unstable.
  • Any patient with an ICD or pacemaker.
  • Patients who are underage and do not have the consent of a parent and/or legal guardian.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: Assessing the Utility of Magnetocardiography in Patients With Hypertrophic Cardiomyopathy

The purpose of this research study is to further establish the diagnostic use of magnetocardiography (MCG) in patients with hypertrophic cardiomyopathy (HCM). The use of MCG has not been extensively studied in these patients. This pilot study will serve to further characterize abnormalities found on MCG in comparison to patients without hypertrophic cardiomyopathy. Additionally, the study will be used to understand whether MCG has any additional diagnostic utility in offering clinicians insight on the patient's disease state, thereby aiding in the development of treatment plans.

This research study is designed to test the effectiveness of the investigational use of magnetocardiography in patients with hypertrophic cardiomyopathy. The device itself has been approved by the U.S Food and Drug Administration (FDA).

Read the detailed description

Patients with hypertrophic cardiomyopathy (HCM) have a gene mutation that results in excessive thickening of heart muscle. Due to this abnormality these patients often present with voltage changes on electrocardiograms (ECG) suggestive of abnormal electrical conduction. The use of magnetocardiography (MCG) in these patients has yet to be extensively studied. Magnetocardiography (MCG) is a safe, non-invasive, and FDA approved technology that can be used to detect weak magnetic fields generated by the heart. The goal of this pilot study is to determine common MCG findings in patients with HCM, while establishing the role that MCG has in the evaluation and treatment of these patients.

We will enroll a total of twenty patients identified to have hypertrophic cardiomyopathy by cardiologists at our facility. As patients' enroll in the study, data will be collected prospectively. We will continue to follow up on patients over the course of 1 year from the date of their initial enrollment. Once a patient has been identified as a candidate for this study, they will be instructed about the risks and benefits of undergoing participation. Informed consent to participate in the study will be obtained for each patient.

We will obtain basic demographic information on our patients including sex, age, race, weight, height, and other co-morbidities and cardiovascular risk factors including, but not limited to family history of syncope, sudden cardiac death, chest pain, or shortness of breath. Information in regards to symptoms experienced, onset of symptoms, previous and current diagnostic workup included blood work and cardiac scans, and current/past treatments will also be recorded. A list of medications will be recorded.

Prior to the MCG scan, the patient will be instructed to wear only non-metallic containing clothing. Patients's will then be requested to lie still on a table for a duration of 6 minutes, while undergoing a magnetocardiography scan. In addition to the MCG, the patient's blood pressure and a 12-lead electrocardiogram will be obtained. Most patients will also have a complete 2D echocardiogram which will require the patient to lie down on a table while an ultrasound probe is placed on the left side of the chest resulting in an image of the heart on a computer screen. In addition to the above, if clinically indicated patients may have blood draws taken at the discretion of their cardiologist. These blood draws may be used to obtain lipid levels, cardiac biomarkers, and natriuretic peptide assays (used to evaluate heart failure).

Once a patient has completed an initial assessment and scan, we will ask the patient to return for follow up visits at 3 months and 1 year for repeat MCG. A 2D ECHO will be obtained at 3 months if clinically indicated, and at 1 year. In addition, we are asking for follow up scans if the patient presents with any cardiac symptoms such as chest pain, shortness of breath, or fainting Follow up phone interview will occur at 6 months. We will ask information regarding symptoms, treatments, hospital admissions, cardiologist visits, and any subsequent diagnostic testing performed including ECGs, transthoracic echos, transesophageal echos, exercise/chemical stress testing, angiograms, and cardiac catheterizations.

Keywords
Hypertrophic Cardiomyopathy(HCM), Magnetocardiography (MCG)
Medical subject headings
Cardiomyopathy, Hypertrophic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionDec 2009 (estimated)
  4. Study completionDec 2009 (estimated)

Why it stopped: sponsor funding

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00574821
Sponsor's protocol ID
11958
Status last verified
Nov 2009
First submitted
14 Dec 2007
Last updated
17 Nov 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertrophic Cardiomyopathy, run by Cedars-Sinai Medical Center 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 5 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: withdrawn, as of the sponsor's last update on 17 Nov 2009. 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 was withdrawn before enrolling participants, so there are no results.

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.

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 17 Nov 2009.

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