- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01749254
Novel Imaging Approaches To Identify Unstable Coronary Plaques
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Midlothian
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Edinburgh, Midlothian, Det Forenede Kongerige, EH16 4SB
- Clinical Research Imaging Centre/ NHS LOTHIAN
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Age > or = 50 yrs. Patients with Acute coronary syndromes or stable coronary artery disease.
Exclusion Criteria:
Insulin dependent diabetes Inability or unwillingness to undergo computed tomography scanning Severe renal failure (serum creatinine >250 µmol/L or estimated glomerular filtration rate <30 mL/min) Known contrast allergy Inability to give informed consent. Females in child bearing age will undergo pregnancy test if pregnancy suspected.
Participation in other research studies requiring exposure to further radiation (over and above mentioned in this study).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Acute Coronary Syndrome
40 patients admitted with ACS (NSTEMI/STEMI) will be recruited undergo 18F NaF PET, 18F FDG and CTCA within 1 month of the event.
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Stable angina cohort
40 patients with previously diagnosed coronary artery disease and listed to undergo elective coronary angiogram will be recruited.
VH-IVUS will be attempted in all patients.
Selected patients will undergo PET scan after stent implantation.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Patients with ACS have focal 18F-NaF uptake and high tissue to background ratio(TBR) and standardised uptake values (SUV) in the culprit vessels.
Tidsramme: Within 1 month of index event
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Using PET/CT, the investigators will assess if there is presence of focal uptake at the areas of plaque ruptures in patients presenting with ACS.
Standardised uptake values and Tissue to Background ratios of the culprit vessels with be compared with non-culprit lesions.
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Within 1 month of index event
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What are the morphological characteristics of plaque with high 18F-NaF tissue to background ratio or standardised uptake value
Tidsramme: 1 month
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Using VH-IVUS, the investigators will look at the morphological characteristics of plaques that have higher SUVs and TBRs.
Additional information about the plaque characteristics will be derived from CT coronary angiogram
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1 month
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Is there a co-relation between the two PET/CT tracers(18FDG and 18F NaF) as measured as Tissue to background ratio or standardised uptake value.
Tidsramme: 1 month
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1 month
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Is there a difference between the coronary and aortic TBR/SUVs in stable and unstable patients
Tidsramme: 1 month
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The investigators will look for differences in activity in stable angina and ACS patients using 18F-NaF and 18F-FDG
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1 month
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Will patients with higher 18F-NaF uptake as measured by SUV/TBR will have higher levels of cardiac biomarkers such as hsCRP or Troponin
Tidsramme: 1 year
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Blood collected from volunteers in the study will be analysed for inflammatory biomarkers such as hsCRP and Troponin
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1 year
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011/R/CAR/13
- ETM/160 (Andet bevillings-/finansieringsnummer: Chief Scientist Office)
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