Klinisk effekt af hjertefotontælling CT
Omfattende karakterisering af koronar aterosklerotisk sygdom ved hjælp af fotontælling-detektor Dual-source CT og dens indvirkning på patientbehandling
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Patienter henvist til koronar hjerte-CT-billeddannelse eller nuklearmedicin eller MR-hjerteperfusion inden for Radiologi eller Kardiologisk Afdeling.
- Patienter, der er i stand til og villige til at underskrive det informerede samtykke, vil blive tilmeldt
- Negativ graviditetstest, hvis forsøgspersonen er i den fødedygtige alder (kvinder i den fødedygtige alder vil blive screenet for graviditet ved hjælp af en uringraviditetstest, som vil blive administreret af enhedsstudiekoordinatoren uden omkostninger for patienten).
Ekskluderingskriterier:
- Patienter, der ikke kan give skriftligt informeret samtykke
- Graviditet
- eGFR ≤ 30
- Anamnese med tidligere moderat eller svær kontrastreaktion omfatter: manglende respons, alvorlig åndedrætsbesvær, kramper, arytmi, hjerte-lungebesvær, progressivt angioødem, larynxødem, dyspnø, bronkospasme, symptomatisk takykardi, symptomatisk bradykardi, hypotension, hypertensiv krise.
- Enhver anamnese med nødvendig præmedicinering før administration af joderet kontrast.
- Patienter, der giver samtykke til deltagelse, men som ikke gennemgår deres klinisk indicerede, kontrastforstærkede CT eller nuklearmedicin eller MR-perfusionsscanning af en eller anden grund (f.eks. dårlig IV, infiltration, reaktion, ændring i indikation).
- Patienter med koronar bypass-transplantater
- Patienter, der oplever atrieflimren, for tidlige ventrikulære kontraktioner eller andre hjerterytmeabnormiteter
- Indlagte patienter eller patienter under pleje i Akutmodtagelsen
Specifikke eksklusionskriterier kun for deltagelse i denne undersøgelses hjertestresstestarm (kræver administration af Regadenoson):
- Alt gennem munden inden for tre timer efter undersøgelsen
- Kendt overfølsomhed over for Regadenoson, Adenosin eller Dipyridamol.
- Aktiv igangværende hvæsen eller dårligt kontrolleret astma eller KOL (indlagt inden for sidste måned eller modtaget behandling for flair inden for sidste måned).
- Anden (type I eller II) eller tredje grads atrioventrikulær (AV) blokering eller sinusknudedysfunktion, medmindre patienten har fungerende kunstig pacemaker.
- Indtaget mere end 4 oz. koffein inden for de sidste 12 timer.
- Oplever i øjeblikket ustabilt koronarsyndrom.
- Ukontrollerbare anfald inden for de sidste 3 måneder
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Clinical Coronary CTA Cohort
Subjects scheduled for a clinically indicated coronary CT angiogram will receive a research contrast-enhanced coronary CT angiogram using photon-counting detector CT.
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Cardiac CT imaging will be performed using a newly developed CT scanner that uses photon-counting detectors and the results compared to those from conventional CT, MRI, or nuclear medicine imaging systems
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Eksperimentel: Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort
Subjects scheduled for a clinically indicated nuclear medicine or MRI cardiac stress test will receive a research contrast-enhanced coronary CT angiogram using photon-counting detector CT at rest and after administration of a cardiac stress agent.
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Cardiac CT imaging will be performed using a newly developed CT scanner that uses photon-counting detectors and the results compared to those from conventional CT, MRI, or nuclear medicine imaging systems
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Arm 1: Change in Clinical Coronary Artery Disease Status Measured in Photon-counting Detector CT Relative to Clinical CT as Measured by Percent Area Stenosis
Tidsramme: Through completion of CT exam, approximately 1 hour
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Percent area stenosis (PAS) measures coronary artery stenosis (blockage) and is defined as the vessel's cross-sectional area in the region of highest stenosis (i.e., most closed) divided by the healthy vessel's cross-sectional area. PAS can range from 0% to 100% with higher percentages indicating worse stenosis. In arm 1, PAS was measured at the site of worst stenosis in each coronary vessel or patient using validated commercial software. For each stenosis, PAS was measured at the same location in the photon-counting detector CT (PCD-CT) angiography scan and in the clinical CT angiography scan (EID-CT). These values were subtracted to get a change in PAS between the clinical EID-CT scan and the PCD-CT scan for each stenosis. Change in PAS impacts patient management. During recruitment, the PCD-CT scanner had a multi-energy ultra-high resolution update allowing a new scan mode that collected x-ray energy data. This mode was used for all patients recruited after the update. |
Through completion of CT exam, approximately 1 hour
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Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting Detector CT at Rest
Tidsramme: Through completion of CT exam, approximately 1 hour
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Sensitivity was calculated as the number of patients correctly identified by the reader as having perfusion defects on photon-counting detector (PCD) CT divided by the total number of patients with perfusion defects.
Specificity was calculated as the number of patients correctly identified by the reader as not having perfusion defects on PCD-CT divided by the total number of patients without perfusion defects.
Sensitivity and specificity can range between 0 and 100%.
All analyzed images were taken when the patient was at rest.
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Through completion of CT exam, approximately 1 hour
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Arm 1: Number of Participants With Decrease in Coronary Artery Disease-Reporting and Data System (CADRADS) Score
Tidsramme: Through completion of CT exam, approximately 1 hour
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Coronary Artery Disease-Reporting and Data System (CADRADS) score is a value assigned to each patient based on the patient's highest percent diameter stenosis (PDS) with higher scores indicating worse stenosis. PDS is defined as the diameter of the stenosed (blocked) coronary vessel divided by the diameter of the healthy vessel. A CADRADs score of 0-5 is assigned to the following PDS values, respectively: 0%, 1-24%, 25-49%, 50-70%, 70-99%, and 100%. A CADRAD score was calculated for each patient in both EID-CT and PCD-CT scans based on the respective PDS for the same lesion. The number of patients whose CADRADS decreased in PCD-CT relative to EID-CT (e.g. 2 on PCD-CT, 3 on EID-CT) is reported below. Change in CADRADS impacts patient management. During recruitment, the PCD-CT scanner had a multi-energy ultra-high resolution update allowing a new scan mode that collected x-ray energy data. This mode was used for all patients recruited after the update. |
Through completion of CT exam, approximately 1 hour
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Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting CT During Cardiac Stress
Tidsramme: Through completion of CT exam, approximately 1 hour
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Sensitivity was calculated as the number of patients correctly identified by the reader as having perfusion defects on photon-counting detector CT (PCD-CT) divided by the total number of patients with perfusion defects.
Specificity was calculated as the number of patients correctly identified by the reader as not having perfusion defects on PCD-CT divided by the total number of patients without perfusion defects.
Sensitivity and specificity can range between 0 and 100%.
All analyzed images were taken after the patient was administered a pharmacological cardiac stress agent to increase heart rate.
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Through completion of CT exam, approximately 1 hour
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cynthia McCollough, PhD, Mayo Clinic
Publikationer og nyttige links
Hjælpsomme 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 (Faktiske)
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
- 21-004933
- R01EB028590 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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