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

NCT07628270 | Recruiting

• 1 other identifier: L2-347
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multivessel Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Patient-Reported Outcomes assessed by Seattle Angina Questionnaire (SAQ)

  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.

  May 2026

• Major Adverse Cerebral and Cardiovascular Events

  Occurrence of major adverse cerebral and cardiovascular events, including all-cause death, myocardial infarction, stroke, and repeat revascularization.

  May 2026

Secondary Outcomes (1)

• Correlation of Lipoprotein(a) with Cardiovascular Outcomes in Complex Coronary Artery Disease

  May 2026

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Universitair Ziekenhuis Brussel: collaborator
• Jena University Hospital: collaborator
• National University of Ireland, Galway, Ireland: collaborator

Study Sites (1)

Centro Cardiologico Monzino; IRCCS

Milan, MI, 20131, Italy

RECRUITING

Central Study Contacts

Gianluca Pontone, MD

CONTACT

0258002574; gianluca.pontone@cardiologicomonzino.it

Saima Mushtaq, MD

CONTACT

0258002679; saima.mushtaq@cardiologicomonzino.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: September 1, 2025
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-04

Locations

IT (1)