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)

Coronary computed tomography angiography (CCTA) is a non-invasive imaging tool that characterizes coronary artery anatomy and provides detailed assessments of plaque morphology, composition , inflammation, and hemodynamics, which have crucial prognostic implications. The FASTTRACK CABG trial demonstrated that CCTA- fractional flow reserve derived from CCTA can plan and guide coronary artery bypass grafting treatment without traditional invasive coronary angiography and provides a valuable dataset of pre- and post-CABG CCTA for further research. This study is a sub-analysis of the FASTTRACK CABG trial and aims first of all to assess whether these imaging-derived markers can predict symptomatic relief and clinical outcomes for patients undergoing CABG, for complex three-vessel or left main coronary artery disease. Moreover, human coronary lesion studies from subjects with sudden death and carotid endarterectomy specimens demonstrate increasing levels of Lipoprotein(a) with lesion progression, peaking in ruptured plaques. Lp(a) is a low-density lipoprotein (LDL)-like particle comprising an apolipoprotein (apoB-100 molecule covalently linked to apo(a). Genome-wide association and Mendelian randomization studies provide strong evidence for the causal association between elevated Lp(a) levels and atherosclerotic cardiovascular diseases (ASCVD) risk. Current clinical guidelines, including the 2022 European Atherosclerosis Society (EAS) consensus, recommend measuring Lp(a) levels at least once in an adult's lifetime. Circulating Lp(a) levels remain relatively stable over a lifetime, making single measurements cost-effective for risk assessment. Established thresholds for high-risk Lp(a) levels are >50 mg/dL or 125 nmol/L, as recognized by assays standardized to WHO/International Federation of Clinical Chemistry guidelines. Epidemiological data suggest that Lp(a) >30 mg/dL increases the risk of coronary heart disease and myocardial infarction, while levels >50 mg/dL elevate the risk of ischemic stroke. Approximately 20-25% of the general population has elevated serum Lp(a) levels. Despite robust evidence linking Lp(a) to ASCVD risk, data correlating Lp(a) levels with coronary artery calcium (CAC) progression remain limited. While Lp(a) and CAC independently predict ASCVD risk, their combined role in guiding prevention strategies is underexplored. Lipoprotein(a)-lowering strategies are currently being investigated in phase 3 cardiovascular outcomes trials. Specifically, the correlation between serum Lp(a) levels and CCTA-derived total calcified plaque volume has yet to be comprehensively studied.

Study Overview

• Status: Recruiting
• Conditions: Multivessel Coronary Artery Disease

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gianluca Pontone, MD; Phone Number: +39 0258002574; Email: gianluca.pontone@cardiologicomonzino.it
• Study Contact Backup: Name: Saima Mushtaq, MD; Phone Number: +39 0258002679; Email: saima.mushtaq@cardiologicomonzino.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20131
      • Recruiting
      • Centro Cardiologico Monzino; IRCCS
      • Contact: Chiara Centenaro; Phone Number: +39 0258002031; Email: chiara.centenaro@cardiologicomonzino.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients of FAST-TRACK CABG trial will be part of these substudies, so patients with left main disease of three-vessel disease who performed CABG procedure guided by CCTA+FFRCT

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes in FAST-TRACK CABG Population	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) as well as major adverse cerebral and cardiovascular events (MACCE) 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..	May 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Lipoprotein(a) with Cardiovascular Outcomes in Complex Coronary Artery Disease	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.	May 2026

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino
• Collaborators: National University of Ireland, Galway, Ireland; Universitair Ziekenhuis Brussel; Jena University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: L2-347

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No