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

16 novembre 2009 aggiornato da: Cedars-Sinai Medical Center

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).

Panoramica dello studio

Stato

Ritirato

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

20

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • California
      • Los Angeles, California, Stati Uniti, 90048
        • Cedars-Sinai Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

16 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

Inclusion Criteria:

  1. 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.
  2. 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.

Exclusion Criteria:

  1. Patients with prior history of myocardial infarction, CAD demonstrated by stress test or angiogram, and/or CABG will be excluded from this study.
  2. 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.
  3. Patients encountering any significant symptoms, chest pain, or who are hemodynamically unstable.
  4. Any patient with an ICD or pacemaker.
  5. Patients who are underage and do not have the consent of a parent and/or legal guardian.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2007

Completamento primario (Anticipato)

1 dicembre 2009

Completamento dello studio (Anticipato)

1 dicembre 2009

Date di iscrizione allo studio

Primo inviato

14 dicembre 2007

Primo inviato che soddisfa i criteri di controllo qualità

14 dicembre 2007

Primo Inserito (Stima)

17 dicembre 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

17 novembre 2009

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 novembre 2009

Ultimo verificato

1 novembre 2009

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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