- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02773043
Evaluation of Myocardial Perfusion Reserve (EVARESERVE)
Studieoversikt
Detaljert beskrivelse
Coronary artery disease is a public health problem. The measurement of myocardial perfusion reserve is a prognostic factor supplemental.
Its measure should influence the treatment and the follow up of the patients. The measurement of CRF by by one pressure-temperature sensor-tipped guide wire is a validated technique to evaluate the myocardial perfusion reserve but it is an invasive technique.
In this study, the investigators will compare this method with a non-invasive method: completely automated analysis and quantification of myocardial blood flow from DICOM files corresponding to stress and rest images was developed with a new camera CZT SPECT.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
La Tronche, Frankrike, 38700
- CHU Michallon
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Myocardial scintigraphy with pharmacologic stress and abnormal results
- Coronarography indicated
- Informed consent
Exclusion Criteria:
- Pregnant woman
- Patient with terminal illness
- Terminal renal failure
- Allergy to iodine
- Informed consent impossible
- Patient under legal protection
- History of coronary artery bypass surgery
- Contraindications for adenosine: asthmatic patients, second or third-degree AV block without pacemaker or sick sinus syndrome. Systolic blood pressure less than 90 mmHg. Recent use of dipyramidole or dipyramidole-containing medications. Methyl xanthenes such as aminophylline caffeine or theobromine block the effect of adenosine and should be held for at least 12 hours prior to the test. Known hypersensitivity to adenosine. Unstable acute myocardial infarction or acute coronary syndrome.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: non invasive imaging technique
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Correlation between the measure of the coronary flow reserve with an invasive reference method (thermodilution) and a new non-invasive method in scintigraphy to measure the myocardial perfusion reserve
Tidsramme: an average of 1 year
|
Coronary flow reserve by thermodilution is the ratio between mean transit time of a room temperature 3-ml bolus of saline during rest and maximal hyperemia. Coronary flow reserve by CZT camera is given by ratio between Mycoardial perfusion during rest and maximal hyperemia. Myocardial perfusion is given by new software. |
an average of 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Evaluation of the myocardial perfusion reserve measuring the CRF by thermodilution.
Tidsramme: an average of 1 year
|
Coronary flow reserve by thermodilution is the ratio between mean transit time of a room temperature 3-ml bolus of saline during rest and maximal hyperemia.
|
an average of 1 year
|
Evaluation of the myocardial perfusion reserve in scintigraphy by the same operator over different time scales and by two different operators.
Tidsramme: an average of 1 year
|
Coronary flow reserve by CZT camera is given by ratio between Mycoardial perfusion during rest and maximal hyperemia.
Myocardial perfusion is given by new software.
|
an average of 1 year
|
Study the correlations between the level of soluble VE-cadherin (sVE) and the other indicators of coronary endothelial involvement (CRF and RMP).
Tidsramme: Day of coronarography
|
Blood test for soluble VE-cadherin (sVE), CRF, RMP
|
Day of coronarography
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Gilles Barone-Rochette, MD, PhD, University Hospital, Grenoble
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 38RC14.214
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