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Prometheus Perfusion Study.


- candidate number7741
- NTR NumberNTR2203
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-feb-2010
- Secondary IDsP07.266 MEC LUMC - substudy
- Public TitlePrometheus Perfusion Study.
- Scientific TitlePrometheus perufsion study: Perfusion scanning in patients aged < or = 50 years with suspected pulmonary embolism - an accuracy study.
- ACRONYM
- hypothesisTo study the accuracy of the PISAPED perfusion scan criteria compared with CT scanning in patients aged < or = 50 years with suspected pulmonary embolism, a likley or high clinical probability and/or an abnormal D-dimer.
- Healt Condition(s) or Problem(s) studiedPulmonary embolism
- Inclusion criteriaIn- or outpatients aged < or = 50 years, with clinically suspected pulmonary embolism, who have a 'likely' (Wells score) or 'high' (revised Geneva score) clinical probability for pulmonary embolism and/or an abnormal D-dimer test and in hwom a cT scan will be made.
- Exclusion criteria1. Age <18 years or > 50 years;
2. Pregnancy;
3 (Low molecular weight) heparin for longer than 48 hours prior to eligibility assessment;
4. Inability to perfom a perfusion scan withing 24 hrs after CT scan;
5. Participation in a therapeutic study for pulmonary embolism is not an exclusion criterion.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2008
- planned closingdate1-okt-2012
- Target number of participants220
- InterventionsPerfusion scintigraphy, chest X-ray and CT scan in patients with likely or high clinical probablity and/or an abnormal D-dimer with suspected pulmonary embolism.
- Primary outcomeThe diagnostic accuracy of the perfsuion scan criteria in comparison to CT scan.
- Secondary outcome1. Positive predictive value;
2. Negative predictive value;
3. Proportion of diagnostic Q scans.
- TimepointsMoment of diagnostic tests to rule out or confirm PE.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD P.W. Kamphuisen
- CONTACT for SCIENTIFIC QUERIESMD P.W. Kamphuisen
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryCT scanning has become a standard test in the diagnostic workup of patients with suspected PE. However, young patients, especially women, likely have an increased risk of (breast) cancer due to radiation exposure with CT scanning. Perfusion scanning has a much lower radiation exposure burden. Therefore, in this study, the accuracy of the PISAPED criteria for the evaluation of perfusion scans for the diagnosis of PE is studied in comparison to CT scan. Patients aged < or = 50 years old with suspected PE who need CT scanning according to current diagnostic work up criteria (i.e. either a 'likely' or 'high' clinical probability or an abnormal D-dimer test) will undergo perfusion scintigraphy. Q scan and CT scan will be compared for the absence or presence of PE.
- Main changes (audit trail)
- RECORD8-feb-2010 - 17-feb-2010


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