- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Gianluca Pontone, MD
- Telefonnummer: +39 0258002574
- E-post: gianluca.pontone@cardiologicomonzino.it
Studera Kontakt Backup
- Namn: Saima Mushtaq, MD
- Telefonnummer: +39 0258002679
- E-post: saima.mushtaq@cardiologicomonzino.it
Studieorter
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MI
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Milan, MI, Italien, 20131
- Rekrytering
- Centro Cardiologico Monzino; IRCCS
-
Kontakt:
- Chiara Centenaro
- Telefonnummer: +39 0258002031
- E-post: chiara.centenaro@cardiologicomonzino.it
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient-Reported Outcomes assessed by Seattle Angina Questionnaire (SAQ)
Tidsram: May 2026
|
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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Correlation of Lipoprotein(a) with Cardiovascular Outcomes in Complex Coronary Artery Disease
Tidsram: 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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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- L2-347
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