- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02617888
Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells
The HEART BREAK Study: Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells
Purpose
- To investigate the effects of cardiac imaging radiation on the induction of DNA double-strand breaks by enumerating gamma-H2AX foci in blood lymphocytes and plucked hair follicle cells.
- To estimate whether the use of breast shields in cardiac computed tomographic angiography (CCTA) limits the effective radiation exposure of breast tissue.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The primary objective of the study is to analyze blood and hair samples from patients undergoing cardiac imaging to estimate radiation exposure levels as well as their biological effects (i.e. to determine the degree of genotoxicity by measuring the amounts of DNA double-strand breaks).
The secondary objective is to investigate whether the use of in-plane breast shielding in female patients undergoing CT angiography (CCTA) limits the radiation exposure of breast tissue and subsequent DNA damage in blood lymphocytes and hair follicle cells.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adult male and female adult subjects (age greater than 18 years)
- Referred for cardiac computed tomography angiography (CCTA), myocardial perfusion scintigraphy (MPS), or diagnostic invasive coronary angiography (ICA).
Exclusion Criteria:
- Female patients that identify themselves as pregnant or have a positive pregnancy test prior to cardiac imaging.
- History (present or past) of leukemia or lymphoma.
- History of radiation therapy
- X-ray examination or scintigraphy within the last 72 hours.
- History of coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention)
- Patients undergoing percutaneous coronary intervention at completion of diagnostic left heart catheterization
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: CCTA Breast Shields
Within female subset, randomization to wearing bismuth breast shield.
|
Breast shield placement (randomized) among women.
Andre navn:
|
Ingen inngripen: CCTA No Breast Shields
Within female subset, randomization to wearing no bismuth breast shield (standard of care).
|
|
Ingen inngripen: Observational Arm
Non-females undergoing CTA and subjects undergoing cardiac catheterization and nuclear medicine testing.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging
Tidsramme: Change from baseline double strand DNA breaks at 30 minutes post-imaging
|
The amount of excess DNA double-strand break foci per cell after cardiac computed tomographic angiography (CCTA) in female patients with and without breast shields, minus the amount of foci prior to CCTA.
In addition, changes in DNA double-strand breaks from baseline following cardiac testing in the observational arm is being assessed in an observational manner.
|
Change from baseline double strand DNA breaks at 30 minutes post-imaging
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 362425
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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. .
Kliniske studier på Koronararteriesykdom
-
IRCCS Policlinico S. DonatoRekrutteringAnomalous aortic origin of the coronary artery (AAOCA)Italia
-
Medtronic CardiovascularFullførtArteriosclerosis of coronary artery bypass graftCanada, Forente stater
-
Lawson Health Research InstituteFullførtArteriosclerosis of arterial coronary artery bypass graftCanada
-
Deutsches Herzzentrum MuenchenFullførtArteriosclerosis of arterial coronary artery bypass graftTyskland
-
William Beaumont HospitalsFullførtKoronararteriesykdom | Arteriosclerosis of coronary artery bypass graftForente stater
-
Izmir Bakircay UniversityFullførtMyocardial Bridge of Coronary ArteryTyrkia
-
ITAB - Institute for Advanced Biomedical TechnologiesAzienda Ospedaliero, Universitaria Ospedali RiunitiFullførtMyocardial Bridge of Coronary ArteryItalia
-
University Hospital OstravaRekrutteringIn-Stent Carotis Artery RestenosisTsjekkia
-
Sohag UniversityHar ikke rekruttert ennåUmblical artery Doppler under termin graviditetEgypt
-
Baylor College of MedicineFullførtLungeblødning | MAPCA - Major Aortopulmonary Collateral ArteryForente stater
Kliniske studier på CCTA ~ BREAST SHIELDS
-
Cardio Med Medical CenterUniversity of Targu Mures, Romania; University Hospital of Targu Mures,...FullførtAterosklerose | Akutt koronarsyndrom | Koronar stenose | Akutt hjerteinfarkt | Ateromatøse plakkRomania
-
Waveguard GmbHUniversity of Stuttgart, Institute of Human Factors and Technology ManagementUkjent
-
Hams Hamed AbdelrahmanAktiv, ikke rekrutterende
-
State University of New York at BuffaloFullførtAterosklerose, koronarForente stater
-
NanovibronixFullført
-
Medtronic Neurovascular Clinical AffairsRekrutteringIntrakraniell aneurisme | Brudd aneurismeForente stater
-
Medical University of GrazFullførtLivskvalitet | Tilfredshet, pasient | Komplikasjoner, Postoperativ/PerioperativØsterrike
-
Tianjin Chest HospitalRekrutteringKoronararteriesykdom | Store uønskede kardiovaskulære hendelser | Koronar computertomografi angiografi | Revaskularisering | Stabil brystsmerter | Optimal medisinsk terapi | Invasiv koronar angiografiKina
-
Fondazione C.N.R./Regione Toscana "G. Monasterio...Turku University Hospital; University of Zurich; Federico II University; Institute... og andre samarbeidspartnereFullførtBehandling/behandling av koronararteriesykdom
-
Aristotle University Of ThessalonikiUkjentKoronararteriesykdom | Aterosklerose | Stabil angina | Aterosklerotisk plakkHellas