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
| NCT ID | NCT07628270 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro Cardiologico Monzino |
| Condition | Multivessel Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-09-01 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07628270 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multivessel Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07628270 currently recruiting?
Yes, NCT07628270 is actively recruiting participants. Contact the research team at gianluca.pontone@cardiologicomonzino.it for enrollment information.
Where is the NCT07628270 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07628270 clinical trial?
NCT07628270 is sponsored by Centro Cardiologico Monzino. The trial plans to enroll 100 participants.