- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07628270
Insights From the FAST-TRACK CABG Trial: a Clinical Outcome Study in Patient With Previous Surgical Revascularization for Complex Three-vessel or Left Main Coronary Artery Disease Based on Coronary Computed Tomography Angiogram, and Fractional Flow Reserve Derived by Computed Tomography (FAST-CABG)
FAST-CABG: Insights From the FAST-TRACK CABG Trial: a Clinical Outcome Study in Patient With Previous Surgical Revascularization for Complex Three-vessel or Left Main Coronary Artery Disease Based on Coronary Computed Tomography Angiogram, (CCTA) and Fractional Flow Reserve Derived by Computed Tomography (FFRCT)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The present study is a observational, prospective, multicenter European study aims to explore in the population of FAST-TRACK CABG the patient-reported outcome measures (by Seattle Angina Questionnaire SAQ) as well as major adverse cerebral and cardiovascular events (MACCE) in FAST TRACK CABG population. Patients meeting all inclusion criteria will be asked to sign an informed consent document.
Clinical outcomes will be collected using Seattle Angina Questionnaire (SAQ). Will be also collected the New York Heart Association (NYHA); MACCE and All-cause death, components of MACCE and cardiovascular hospitalization.
During this visit, the value of Lp (a), which was previously dosed according to the guidelines, will also be recorded
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Gianluca Pontone, MD
- Telefonnummer: +39 0258002574
- E-mail: gianluca.pontone@cardiologicomonzino.it
Undersøgelse Kontakt Backup
- Navn: Saima Mushtaq, MD
- Telefonnummer: +39 0258002679
- E-mail: saima.mushtaq@cardiologicomonzino.it
Studiesteder
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MI
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Milan, MI, Italien, 20131
- Rekruttering
- Centro Cardiologico Monzino; IRCCS
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Kontakt:
- Chiara Centenaro
- Telefonnummer: +39 0258002031
- E-mail: chiara.centenaro@cardiologicomonzino.it
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients who have analyzable pre-CABG CCTA imaging and received a successful CCTA-guided plus FFRCT CABG procedure.
- Patient with known level of Lp(a) or with possibility to perform the test
- Patent able to provide written informed consent as approved by the Ethical Committee
Exclusion Criteria:
- Patients without pre-CABG CCTA imaging or those with who did not receive surgical revascularization.
- Current treatment with lipoprotein apheresis
- Patients who refuse to receive clinical follow-up
- Unable to give Informed Consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Prospective Cohort
Patients enrolled in a prior clinical trial undergoing follow-up for the assessment of patient-reported outcomes (SAQ), MACCE, and biomarker correlations, including serum lipoprotein(a) levels
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Patient-Reported Outcomes assessed by Seattle Angina Questionnaire (SAQ)
Tidsramme: May 2026
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The primary aim of this study is to explore in the population of FAST-TRACK CABG the patient-reported outcome measures (by Seattle Angina Questionnaire SAQ) in FAST TRACK CABG population.
In coronary artery disease, the Seattle Angina Questionnaire (SAQ) has emerged as the most commonly used measure of disease-specific health status to quantify patients' symptoms of angina and the degree to which their angina impacts their function and quality of life.
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May 2026
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Major Adverse Cerebral and Cardiovascular Events
Tidsramme: May 2026
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Occurrence of major adverse cerebral and cardiovascular events, including all-cause death, myocardial infarction, stroke, and repeat revascularization.
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May 2026
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Correlation of Lipoprotein(a) with Cardiovascular Outcomes in Complex Coronary Artery Disease
Tidsramme: May 2026
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The secondary objectives of this study are to evaluate if serum Lp(a) levels improve the predictive capacity of imaging biomarkers in predicting MACCE; to evaluate the correlation between serum Lp(a) levels and CCTA-derived total plaque volume, high risk plaque features, in patients with complex three-vessel or left main coronary artery disease (CAD) participating in the FASTTRACK CABG Trial.
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May 2026
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
Andre undersøgelses-id-numre
- L2-347
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Multikar koronararteriesygdom
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IRCCS Policlinico S. DonatoRekrutteringAnomalous aorta origin of the coronary artery (AAOCA)Italien
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IRCCS Policlinico S. DonatoUniversity of Pavia; University of Naples; The Mediterranean Institute for...RekrutteringMyokardieiskæmi | Pludselig hjertedød | Anomal koronararterieoprindelse | Anomal koronararterie, der opstår fra den modsatte sinus | Anomal koronararterie med aorta-oprindelse og forløb mellem de store arterier | Anomalous aorta origin of the coronary artery (AAOCA) | Myokardieiskæmi, Angina Pectoris og andre forholdItalien