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Magnetic Resonance Imaging to Identify Characteristics of Plaque Build-Up in People With Peripheral Arterial Disease

7. april 2014 opdateret af: Mary McDermott, Northwestern University

Magnetic Resonance in Peripheral Arterial Disease

Peripheral arterial disease (PAD) is a disease in which fatty build-up, or "plaque," accumulates in the peripheral arteries. People with PAD often experience leg pain while walking due to reduced blood flow to the legs. This study will use magnetic resonance imaging (MRI) techniques to examine how specific features of plaque build-up in the leg arteries affect walking ability, leg strength, and balance in people with PAD.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

Plaque build-up caused by atherosclerosis increases the risk of blood clots, heart attack, and stroke. Blockages of plaque can occur in different areas of the body. PAD, a circulatory disorder in which blockages occur in the peripheral arteries, is one manifestation of atherosclerosis. Individuals with PAD experience reduced blood flow to the legs, which may cause leg pain while walking. This study will use MRI techniques to examine how characteristics of plaque build-up in the leg arteries change over time and how this change affects function, walking ability, leg strength, and balance in people with PAD. Results from this study may be used to shape future research studies that will attempt to identify more effective treatments for people with PAD.

This study will enroll people with PAD, as well as a smaller control group of people who do not have PAD. At an initial study visit, study researchers will interview participants to collect information about their medical history, daily activity level, walking ability, and mental functioning. Blood collection and a leg MRI will occur. Also, blood flow to the legs will be measured by comparing blood pressure measurements in the arms and legs. Leg function will be measured through a series of timed walks, leg strength exercises, and muscle power exercises. Questionnaires to assess participants' medical history will be completed by each participant's primary care doctor, and study researchers will review participants' medical records. Participants with knee pain will have a knee x-ray, and participants may wear a small device called an accelerometer for 1 week to monitor physical activity levels. During the second and third study visits, occurring at one and two year follow-up, blood flow, leg function, and leg strength will be measured. If participants cannot attend either study visit, researchers may visit participants at their home or conduct an interview over the phone. Study researchers may contact participants by phone once or twice a year for follow-up.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

519

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Ankle Brachial Index less than 1 in participants

Beskrivelse

Inclusion Criteria:

  • For participants with PAD: lowest leg ankle-brachial index (ABI) less than or equal to 0.999
  • For participants in the control group: lowest ABI between 1.00 to 1.30

Exclusion Criteria:

  • Foot amputation, leg amputation, or gangrene
  • Recent liver transplantation
  • Requires oxygen on ambulation
  • End stage renal disease
  • Confined to a wheelchair
  • Lives in a nursing home
  • Low life expectancy
  • Mini-Mental Status Exam (MMSE) score of less than 23 out of 30
  • Communication difficulty due to language barriers
  • Inability to tolerate MRI testing for any reason
  • Six-minute walk performance limited primarily by pulmonary disease, legal blindness, or severe lower extremity arthritis

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Functional Performance: 6-minute walk performance
Tidsramme: Baseline, 12 months, 24 months
Baseline, 12 months, 24 months
MRI: Mean Plaque Volume
Tidsramme: Baseline, 24 months
Baseline, 24 months

Sekundære resultatmål

Resultatmål
Tidsramme
Four meter walking velocity (usual pace), four meter walking velocity (fastest pace), SPPB
Tidsramme: Baseline, 12 months, 24 months
Baseline, 12 months, 24 months
MRI: maximum plaque volume, external remodeling, mean percent lumen reduction, maximum percent lumen reduction
Tidsramme: Baseline, 24 months
Baseline, 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Mary M. McDermott, MD, Northwestern University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2007

Primær færdiggørelse (Faktiske)

1. januar 2012

Studieafslutning (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først indsendt

23. august 2007

Først indsendt, der opfyldte QC-kriterier

23. august 2007

Først opslået (Skøn)

24. august 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1396
  • R01HL083064-01A2 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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