Novel Imaging Approaches To Identify Unstable Coronary Plaques
18. juni 2021 oppdatert av: University of Edinburgh
Cardiovascular disease is the leading cause of death in Scotland and the Western World.
Approaches to improve the identification of vulnerable or ruptured coronary atherosclerotic plaques are urgently needed to help risk stratification, to identify patients for intensive therapies, and to provide novel biomarkers for the development of anti-atherosclerotic drug interventions.
Using positron emission tomography, we have recently shown that sodium 18-fluoride uptake holds major promise as a novel marker of plaque vulnerability and rupture.
Here we wish to characterise coronary atherosclerotic plaque using 128-multidetector computed tomography combined with 18-fluorodeoxyglucose and sodium 18-fluoride positron emission tomography and Virtual histology-intravascular ultrasound in 80 patients with stable and unstable coronary artery disease.
This has the potential to provide an innovative and highly valuable translational model with which to test novel therapeutic interventions targeted at reducing atheroma and plaque rupture.
This could have major implications for the future treatment of cardiovascular disease.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
80
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Midlothian
-
Edinburgh, Midlothian, Storbritannia, EH16 4SB
- Clinical Research Imaging Centre/ NHS LOTHIAN
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The investigators will recruit two populations of 40 patients each.
The first population will be patients with known stable coronary heart disease.
They will have previously documented and angiographically proven coronary artery disease (≥70% luminal stenosis of a major epicardial vessel).
The second population will be patients with a recent (within 30 days) acute myocardial infarction defined by the Universal definition of myocardial infarction.
The culprit plaque will be defined according to the invasive coronary angiogram appearances, electrocardiogram and clinical features by two cardiologists blinded to the results of positron emission tomography.
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
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.
|
Within 1 month of index event
|
|
What are the morphological characteristics of plaque with high 18F-NaF tissue to background ratio or standardised uptake value
Tidsramme: 1 month
|
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
|
1 month
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
|
1 month
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Is there a difference between the coronary and aortic TBR/SUVs in stable and unstable patients
Tidsramme: 1 month
|
The investigators will look for differences in activity in stable angina and ACS patients using 18F-NaF and 18F-FDG
|
1 month
|
|
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
|
Blood collected from volunteers in the study will be analysed for inflammatory biomarkers such as hsCRP and Troponin
|
1 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2012
Primær fullføring (Faktiske)
1. april 2015
Studiet fullført (Faktiske)
1. april 2015
Datoer for studieregistrering
Først innsendt
30. november 2012
Først innsendt som oppfylte QC-kriteriene
11. desember 2012
Først lagt ut (Anslag)
13. desember 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. juni 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juni 2021
Sist bekreftet
1. juni 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2011/R/CAR/13
- ETM/160 (Annet stipend/finansieringsnummer: Chief Scientist Office)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .