- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01749280
Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms
11 december 2012 uppdaterad av: University of Edinburgh
Efficacy of Magnetic Resonance Imaging Using Ultrasmall Superparamagnetic Particles of Iron Oxide to Predict Clinical Outcome in Patients Under Surveillance for Abdominal Aortic Aneurysms
The aorta is the main blood vessel that comes out of the heart and distributes blood to the whole body.
In some people, the aorta becomes swollen (aneurysm) and bursts, especially as it passes through the abdomen.
These 'abdominal aortic aneurysms' often occur without symptoms and can burst or rupture without warning.
This usually leads to death and represents the thirteenth commonest cause of death in the United Kingdom.
In this study, we are looking at a new technique that can look at the aortic aneurysm using magnetic resonance imaging; a technique that does not require x-rays or radiation.
We have recently shown that, using magnetic resonance combined with a new imaging agent USPIO, we can detect 'hotspots' of activity in these aneurysms that seem to predict which aneurysms grow rapidly, and are therefore potentially at risk of rupture.
We here propose to conduct a study in Edinburgh that will invite all patients who are under surveillance because of an aneurysm.
We will image these patients using this novel technique and see if we can identify which patients burst their aneurysm, have an aneurysm that grows so large it needs to have surgery, or die.
This will be important to establish as it will potentially lead to a new way of managing people that could ultimately save lives.
This is particularly timely as national screening and surveillance programmes are currently being launched.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
HYPOTHESIS We hypothesise that uptake of ultrasmall supraparamagnetic particles of iron oxide into the aortic wall will predict abdominal aortic aneurysm growth and clinical outcomes.
Studietyp
Observationell
Inskrivning (Faktisk)
16
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Edinburgh, Storbritannien, EH16 4SB
- Clinical Research Imaging Centre/ NHS LOTHIAN
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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
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
The investigators will recruit 237 patients with abdominal aortic aneurysms from the clinical surveillance programme at the Royal Infirmary, Edinburgh.
Inclusion criteria will be patients with an abdominal aortic aneurysm >40 mm on ultrasound scanning.
Exclusion criteria will include patients with anticipated or planned abdominal aortic aneurysm repair, women of child-bearing potential without contraception, inability to undergo magnetic resonance or computed tomography scanning, life expectancy of <2 years, and those with any form of collagen-vascular disease.
Beskrivning
Inclusion Criteria:
Patients with an abdominal aortic aneurysm >40 mm
Exclusion Criteria:
- Any medical history or clinically relevant abnormality identified on the screening medical examination, vital sign measurement, or clinical laboratory examination that is deemed by the principal investigator and/or designee to make the subject ineligible for inclusion.
- Subjects with planned AAA surgery.
- Renal impairment with eGFR of <30 mls/min at screening, history of kidney transplant or history of contrast nephropathy.
- Women of child-bearing potential without contraception,
- Collagen-vascular disease.
- Inability to undergo magnetic resonance or computed tomography scanning,
Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes but not limited to:
- Intracranial aneurysm clips (except Sugita) or other metallic objects,
- History of intra- orbital metal fragments that have not been removed,
- Pacemakers, implantable cardiac defibrillators and non-MR compatible heart valves,
- Inner ear implants,
- History of claustrophobia in MR.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Abdominal Aortic Aneurysms
Patients will be recruited from the outpatient AAA surveillance population at the vascular unit in the Royal Infirmary of Edinburgh.Potential participation in the study will be completely asymptomatic from their AAA.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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To determine if uptake ultrasmall superparamagnetic particles of iron oxide as determined by percentage R2* change between pre-and post-constant scan will predict abdominal aortic aneurysm growth and rupture in patients with abdominal aortic aneurysms.
Tidsram: 2 yrs
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The change of R2* signal which is determined by the USPIO uptake within the issues will be used to assess the change between pre-and post contrast MRI scans.
The investigators will assess if macrophage activity as determined by USPIO change predicts AAA growth and rupture
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2 yrs
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Does USPIO uptake as determined by percentage change between pre-and post contrast scan co-relates with FDG PET standardised uptake values or tissue to background ratios.
Tidsram: 2 yrs
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As per ethical approval, we have recruited patients under AAA PET study to look at USPIO correlation with 18F-FDG PET.
The cellular inflammation can be assessed by USPIO uptake, whilst the metabolic activity can be determined by 18F-FDG PET.
In this study, the investigators will determine if there is a correlation between the these two imaging modalties by comparing the R2* change using MRI and standardised uptake values using FDG PET.
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2 yrs
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: David Newby, MD PhD, University of Edinburgh
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
1 mars 2011
Primärt slutförande (Faktisk)
1 augusti 2012
Avslutad studie (Faktisk)
1 augusti 2012
Studieregistreringsdatum
Först inskickad
30 november 2012
Först inskickad som uppfyllde QC-kriterierna
11 december 2012
Första postat (Uppskatta)
13 december 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
13 december 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 december 2012
Senast verifierad
1 december 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2011/R1CARl05
- 10336 (Registeridentifierare: UKRCN)
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 .