Annexin Imaging in Dissection of the Descending Aorta (PAIDDA)
8. februar 2019 opdateret af: Assistance Publique - Hôpitaux de Paris
Prognostic of Annexin Imaging in Dissection of the Descending Aorta
The relationship between the presence of a partial thrombus and aortic dilation after type B dissection has recently been reported.
The originality lies in the idea of imaging thrombus activity to predict dilation after type B dissection.
The innovative character is based on the use of annexin scintigraphy.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
To establish the proof of concept in humans of the link between the intensity of 99mTc-annexin V-128 binding in the descending thoracic aorta and the progression of aortic diameter in patients with type B aortic dissection.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
83
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Olivier Milleron, MD
- Telefonnummer: 00 33 1 40 25 68 16
- E-mail: olivier.milleron-ext@aphp.fr
Studiesteder
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-
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Paris, Frankrig, 75018
- Service de Cardiologie - Hôpital Bichat Claude Bernard
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Kontakt:
- Olivier Milleron, MD
- Telefonnummer: 00 33 1 40 25 68 16
- E-mail: olivier.milleron-ext@aphp.fr
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- patient whose age is ≥ 18 years old
- any patient seen more than 6 months and less than 5 years after a dissection involving the descending aorta at Bichat Hospital, whether it is a dissection of the descending aorta alone or a dissection of the ascending aorta extended to the descending aorta
- dissection of the uncomplicated descending thoracic aorta: not requiring surgery or stent implantation within the first 6 months after acute dissection
- effective contraception for women of childbearing age
Exclusion Criteria:
- scheduled procedure for dissection of the descending aorta
- contraindication to aortic CT with injection of contrast media: renal failure with creatinine clearance <30 ml/min or creatinine >200 µmol/l; allergy to contrast media
- history of surgery or stent implantation in the descending thoracic aorta
- pregnant or breastfeeding women
- patient under guardianship or trusteeship
- non affiliation to social security or CMU (beneficiary or assignee)
- patient refusal to participate in the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Annexin
All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)
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All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation between the rate of expansion of the aortic diameter and the intensity of attachment of the annexin by the aortic wall descending
Tidsramme: 30 months
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Pearson correlation coefficient between the rate of expansion of the aortic diameter measured by CT (at 6 months, 18 months and 30 months) in mm/year (at the site of maximum expansion) and the intensity of attachment of the annexin by the aortic wall descending in scintigraphy.
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30 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve.
Tidsramme: 30 months
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Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve.
The cut-off point will be defined by the Youden index.
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30 months
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Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)
Tidsramme: 30 months
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Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)
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30 months
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Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)
Tidsramme: 30 months
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Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)
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30 months
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Morphological characteristics of the wall thrombus
Tidsramme: 30 months
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Morphological characteristics of the wall thrombus: no thrombus of the false lumen, partial thrombosis or total thrombosis of the false lumen.
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30 months
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Determination of potential predictive clinical factors of aortic dilation rate
Tidsramme: 30 months
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Determination of potential predictive clinical factors of aortic dilation rate: age, blood pressure, heart rate, sex, history of dissection, etiology (Marfan or no Marfan)
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30 months
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Determination of potential predictive SPECT factors of aortic dilation rate
Tidsramme: 30 months
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Determination of potential predictive SPECT factors of aortic dilation rate: anormal annexin binding, ratio of annexin binding (TBR = Target-to-Background Ratio)
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30 months
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Determination of potential predictive biological factors of aortic dilation rate
Tidsramme: 30 months
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Determination of potential predictive biological factors (C-Reactive Protein) of aortic dilation rate
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30 months
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Determination of potential predictive morphological factors of aortic dilation rate
Tidsramme: 30 months
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Determination of potential predictive morphological factors of aortic dilation rate: no thrombus, partial thrombosis or total thrombosis.
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30 months
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Number of cardiovascular events
Tidsramme: 30 months
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Number of cardiovascular events: cardiovascular death, dissection complications (including aortic rupture, malperfusion, emboli), aortic surgery.
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30 months
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Evaluation of the tolerance of the annexin scintigraphy by collecting side effects occurence
Tidsramme: 3 days
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Tolerance of the annexin scintigraphy will be assessed using a questionnaire during a phone call at day 3 to ask the patients about side effects occurrence.
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3 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Olivier Milleron, MD, Assistance Publique - Hôpitaux de Paris
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 (Forventet)
1. maj 2019
Primær færdiggørelse (Forventet)
31. maj 2024
Studieafslutning (Forventet)
31. december 2024
Datoer for studieregistrering
Først indsendt
10. september 2018
Først indsendt, der opfyldte QC-kriterier
4. februar 2019
Først opslået (Faktiske)
6. februar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. februar 2019
Sidst verificeret
1. september 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- P1700905J
Plan for individuelle deltagerdata (IPD)
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