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Technical Development of Strain Rate Echocardiography

This study will examine heart function using two imaging techniques - echocardiography (ultrasound) and magnetic resonance imaging (MRI) - to evaluate newly developed software for echocardiograph machines. MRI and ultrasound both provide images of the heart structure and function. MRI uses a magnetic field and radio waves to obtain the pictures, while echocardiography uses sound waves.

Patients with any form of heart disease and healthy volunteers 21 years of age and older may be eligible for this study. Candidates must be and able to undergo magnetic resonance imaging and must not have an irregular heart rhythm, heart valve disease, a pacemaker, defibrillator implant, insulin pump, or other metallic implant.

Participants will have two ultrasound examinations and two magnetic resonance imaging examinations, as described below. All the tests will be completed within 24 to 48 hours.

Echocardiography :

For this test, a small probe is passed over the chest. Sound waves emitted from the probe bounce off the heart and are beamed back into the echo machine where they are recorded. The sonographer does a baseline test, which is evaluated by the physician. Then, after a 10- to 20-minute break, portions of the test are repeated. The entire exam takes about 2 hours.

Magnetic Resonance Imaging:

For MRI, the subject lies on a table that slides into a long doughnut-shaped scanner. A small tube is placed in a vein in the hand or arm to give fluids and to infuse gadolinium, a contrast material that brightens the images. Heart rate and blood pressure are monitored during the study, which takes about 3 hours.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

The purpose of this protocol is to study the reproducibility of strain rate (SR) echocardiography in normal volunteers and patients with cardiovascular disease. Tissue Doppler ultrasound is a technology which has been validated for the analysis of global and regional left ventricular function and strain and SR measurements are derived from tissue Doppler imaging (TDI) data. Over the last few years, several improvements in echo machine hardware and software have facilitated the rapid acquisition and analysis of tissue Doppler data, and therefore, strain and strain rate information has become easily accessible. Recent publications have demonstrated the usefulness of these techniques in the analysis of systolic and diastolic function of the left ventricle, and in the detection of regional wall motion and ischemia. Several protocols recently initiated in the Cardiovascular Branch involve echocardiographic imaging and include applications of TDI as their primary or secondary endpoints. Therefore, the purpose of this protocol is to allow development of standardized acquisition and analysis methods of TDI for our cardiology protocols and to evaluate the reproducibility of TDI, SR, and strain measurements.

Studietype

Observasjonsmessig

Registrering

125

Kontakter og plasseringer

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Studiesteder

    • Maryland
      • Bethesda, Maryland, Forente stater, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

  • INCLUSION CRITERIA:

Adults older than 18 years will be recruited for the CAD group. Since regional wall motion abnormalities, coronary artery disease, and heart failure are rare in subjects under 21, we will limit this group to adults only.

Adults older than age 18 who have undergone surgical repair of Tetralogy of Fallot will be recruited. Normal controls will be age-matched to this group of patients.

Able to provide written informed consent.

EXCLUSION CRITERIA:

Patients with pulmonary artery shunts placed within the last 6 months are not eligible to undergo MRI scanning.

Pregnant or lactating (patients with uncertain pregnancy status will be required to have a screening urine or blood pregnancy test).

Chronic atrial fibrillation; frequent PVC's (more than 1 every 10 heart beats).

Cardiac pacemaker, defibrillator, or other metallic implant which would exclude subject from MRI examination (examples: central nervous system aneurysm clips, implanted neural stimulator, cochlear implant, ocular foreign body, insulin pump, metal shrapnel or bullet).

Inability to provide written informed consent.

Patients with hemoglobinopathies or renal disease with a creatinine clearance (CrCl) less than 20 ml/min will be excluded from MRI sequences involving administration of MRI contrast agents.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

8. januar 2004

Studiet fullført

17. oktober 2007

Datoer for studieregistrering

Først innsendt

11. januar 2004

Først innsendt som oppfylte QC-kriteriene

10. januar 2004

Først lagt ut (Anslag)

12. januar 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2017

Sist bekreftet

17. oktober 2007

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 040082
  • 04-H-0082

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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