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Imaging of Totally Blocked Arteries

Gadofosveset Imaging of Chronic Total Peripheral Artery Occlusion (CTO)

This study will test how well a new contrast agent (dye) used in magnetic resonance imaging (MRI) can help visualize totally blocked arteries that normally supply blood to the neck, arms or legs. Currently used agents work well in visualizing normal or partly blocked arteries (arteries that have some blood flowing through them), but only poorly in totally blocked arteries. This study will see if a contrast agent called gadofosveset can better brighten images of completely blocked arteries. Gadofosveset is approved in Europe for use in MRI scans, but is still considered experimental in the United States.

People 18 years of age or older with known or suspected total blockage of an artery to the neck, arm or leg may be eligible for this study.

Participants undergo MRI scanning with gadofosveset contrast dye. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the subject lies on a table that can slide in and out of the tubular scanner, wearing earplugs to muffle loud noises that occur during the scanning process. The procedure lasts about 1.5 to 2 hours, during which the subject may be asked to hold his or her breath several times for as long as 5 to 20 seconds. During the procedure, gadofosveset is injected and several kinds of MRI pictures are taken to understand better how the new agent works. Subjects may be asked to undergo a second scan using conventional MRI contrast dye

Studieöversikt

Detaljerad beskrivning

Repairing totally occluded peripheral arteries remains challenging because they are not visualized using available imaging technologies. Contrast-enhanced magnetic resonance angiography (CE-MRA), X-ray computed tomography angiography (CTA), and invasive radiocontrast digital subtraction angiography (DSA) all rely on blood flow within arteries that are not totally occluded. Where the arterial lumen is totally occluded, contrast does not enter and the artery remains invisible. As a result, physicians have difficulty identifying a pathway or trajectory for catheter devices in order to improve blood flow using angioplasty.

Gadofosveset, an albumin-binding MRI contrast agent that is commercially available outside the United States, may accumulate in the walls of occluded arteries through a mechanism that is not known.

The goal of this protocol is to determine whether gadofosveset has value in planning catheter trajectories in totally occluded peripheral arteries. We propose to study the gadofosveset contrast enhancement patterns in occluded peripheral artery segments in up to 20 patients with known occluded iliac, femoral, and shoulder arteries being considered for catheter-based treatment.

This research may have value in planning and conducting minimally invasive treatments using conventional X-ray guidance and possibly in the future using investigational real-time MRI guidance.

Studietyp

Interventionell

Inskrivning

20

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Maryland
      • Bethesda, Maryland, Förenta staterna, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

  • INCLUSION CRITERIA:

Subjects with known cardiovascular disease will be eligible for participation in this protocol. The subject is eligible under the following conditions:

  • Subject's age is greater than 18 years of age.
  • Known occlusion of iliac, femoral, or brachiocephalic arteries.

EXCLUSION CRITERIA:

Subjects with absolute contraindications to MRI scanning will be excluded. These contraindications include subjects with the following devices:

  • Implanted cardiac pacemaker or defibrillator.
  • Central nervous system aneurysm clips.
  • Implanted neural stimulator.
  • Cochlear implant.
  • Ocular foreign body (e.g. metal shavings).
  • Insulin pump.
  • Metal shrapnel or bullet.

When subjects can provide evidence that their implanted device is labeled compatible with MRI, exceptions to the above exclusions can be made and recorded in the note.

Furthermore, certain subject groups will be excluded because of the administration of MRI contrast agents. The weight limit is related to availability of investigational contrast agents. Because of recent concerns about Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy after gadobenate exposure in patients with end-stage renal disease, renal excretory function will be determined and patients with severe renal excretory dysfunction are excluded from this research protocol.

  • Pregnant women (subjects who are uncertain as to whether they are pregnant will be required to have a quantitative serum pregnancy test within 72 hours) or lactating women.
  • Subjects who have experienced an allergic reaction to gadolinium-based contrast agents.
  • Subjects with hemoglobinopathies.
  • Weight greater than 120 kg.
  • Subjects with renal disease (eGFR less than 30 ml/min/1.73m(2), or receiving renal replacement therapy).

The creatinine clearance will be estimated in all subjects as an estimated glomerular filtration rate (eGFR) using the abbreviated MDRD Formula.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vad mäter studien?

Primära resultatmått

Resultatmått
Conspicuity of occluded arteries after contrast exposure.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

5 april 2007

Primärt slutförande (Faktisk)

25 november 2008

Studieregistreringsdatum

Först inskickad

11 april 2007

Först inskickad som uppfyllde QC-kriterierna

11 april 2007

Första postat (Uppskatta)

12 april 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 juli 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juni 2017

Senast verifierad

25 november 2008

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på MS-325 Injection (Gadofosveset Trisodium)

3
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