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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

Study acronym: FAST-CABG
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jul 31, 2026 → Oct 31, 2026
See other at-risk trials from Centro Cardiologico Monzino

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary and study completion pushed from Jul 31, 2026 to Oct 31, 2026
    • Eligibility criteria expanded, about 7 words
  2. Minor Primary and study completion pushed from May 31, 2026 to Jul 31, 2026v3
  3. Notable Primary endpoint(s) modifiedv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07628270
Lead Sponsor Centro Cardiologico Monzino
Collaborators: Universitair Ziekenhuis Brussel, Jena University Hospital, National University of Ireland, Galway, Ireland
Conditions
(from sponsor)
Multivessel Coronary Artery Disease
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov