- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00720460
Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Normal Volunteers
Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Healthy Volunteers
This study will test new techniques to image the heart, blood vessels, and legs using magnetic resonance imaging (MRI). The techniques will be used to plan and guide treatments using minimally invasive methods.
Healthy normal volunteers 18 years of age and older may be eligible for this study.
For MRI, the subject lies flat on a table that can slide in and out of the scanner, a metal cyclinder. Special antennas, covered in pads, are placed against the subject s body. The scan time can vary from 20 minutes to 2 hours, with most scans lasting between 45 and 90 minutes. The subject may be asked to wear adhesive patches on the chest for monitoring the heart and a belt or finger pad for monitoring breathing. During the test, a contrast agent called gadolinium may be injected. This substance brightens the heart and arteries during the scan, providing a better picture of blood flow.
During the procedure, subjects may be asked to exercise their legs on a machine to evaluate the effects of motion and exercise on the MRI exam.
Large blood pressures cuffs may be placed on either or both thighs or calves to try to measure arterial flow to the legs. The cuffs are inflated to a pressure as high as at least 50 mmHg higher than thesubject s systolic blood pressure (up to 250 mmHg) for up to 10 minutes.
Subjects may be asked to return for repeated scans.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Maryland
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Bethesda, Maryland, Forente stater, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
- 1. GENERAL INCLUSION CRITERIA:
Healthy adult volunteers, age is greater than 18 years of age, who consent to participate in writing
2. EXCLUSION CRITERIA: MRI risk
- Cardiac pacemaker or implantable defibrillator
- Cerebral aneurysm clip
- Implanted neural stimulator (e.g. TENS-Unit)
- Any type of ear or cochlear implant
- Intra-ocular foreign body (e.g. metal shavings)
- Any implanted device (e.g. insulin pump, drug infusion device)
- Metal shrapnel or bullet
- Morbid obesity
Claustrophobia
3. EXCLUSION CRITERIA: Contrast media risk:
- Pregnant women (when uncertain, subjects will undergo urine or blood testing) or lactating women
- Known hemoglobinopathy
- Known kidney disease
- Exposure to gadolinium MRI contrast agents in the past 18 hours, if the study requires gadolinium MRI contrast agent.
- Diabetes
- Children are not included.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Experimental
Healthy Volunteers
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
To develop and test new and incremental approaches to fast cardiovascular MRI in healthy human subjects. (healthy volunteers)
Tidsramme: Day of study
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There are 24 objectives listed in the protocol as potential outcomes.
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Day of study
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Haustein J, Laniado M, Niendorf HP, Louton T, Beck W, Planitzer J, Schoffel M, Reiser M, Kaiser W, Schorner W, et al. Triple-dose versus standard-dose gadopentetate dimeglumine: a randomized study in 199 patients. Radiology. 1993 Mar;186(3):855-60. doi: 10.1148/radiology.186.3.8430199.
- Niendorf HP, Haustein J, Cornelius I, Alhassan A, Clauss W. Safety of gadolinium-DTPA: extended clinical experience. Magn Reson Med. 1991 Dec;22(2):222-8; discussion 229-32. doi: 10.1002/mrm.1910220212.
- Lederman RJ. Cardiovascular interventional magnetic resonance imaging. Circulation. 2005 Nov 8;112(19):3009-17. doi: 10.1161/CIRCULATIONAHA.104.531368. No abstract available.
- Saybasili H, Kellman P, Griswold MA, Derbyshire JA, Guttman MA. HTGRAPPA: real-time B1-weighted image domain TGRAPPA reconstruction. Magn Reson Med. 2009 Jun;61(6):1425-33. doi: 10.1002/mrm.21922.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 080185
- 08-H-0185
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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