Safety and Feasibility Evaluation of Planning and Execution of Surgical Revascularization Solely Based on Coronary CTA and FFRCT in Patients With Complex Coronary Artery Disease (FASTTRACK CABG)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    114
  • sponsor
    National University of Ireland, Galway, Ireland
Updated on 26 January 2021
arteriopathy
angiography
ct scan
computed tomography angiography
electrocardiogram
renal function
coronary artery disease
myocardial infarction
infarct
troponin
ischemia
bypass graft
beta blockers
acute coronary syndrome
beta blocker
coronary artery bypass graft
beta-blockers
claustrophobia
coronary disease
functional assessment
arterial disease
stenotic
coronary bypass
alesion
beta-adrenergic blocking agents
troponin i
revascularisation

Summary

To assess the feasibility of coronary computed tomography angiography (CTA) and fractional flow reserve derived from CTA (FFRCT) to replace invasive coronary angiography (ICA) as a surgical guidance method for planning and execution of coronary artery bypass graft (CABG) in patients with 3-vessel disease with or without left main disease. The FASTTRACK CABG study is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept, and first-in-man study with feasibility and safety analysis. Surgical revascularization strategy and treatment planning will be solely based on coronary CTA and FFRCT without knowledge of the anatomy defined otherwise by ICA that will be viewed and analyzed only by the conventional heart team. Clinical follow-up visit including coronary CTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularization with respect to the surgical planning based on non-invasive imaging with functional assessment and compared to ICA. Primary feasibility endpoint is CABG planning and execution solely based on coronary CTA in 114 patients. Primary safety endpoint based on 30-day coronary CTA is graft assessment either at the ostium, in the shaft or at the anastomoses of each individual graft either single or sequential. The FASTTRACK CABG study is the first study to assess safety and feasibility of planning and execution of surgical revascularization in patients with complex coronary artery disease, solely based on coronary CTA combined with FFRCT.

Details
Condition Coronary Artery Disease, Coronary heart disease, Vascular Diseases, Heart disease, Cardiovascular Disease, Arterial Occlusive Disease, Atherosclerosis, Arteriosclerosis, Ischemic Heart Disease, Occlusions, Cardiac Ischemia, Myocardial Ischemia, Cardiac Disease, coronary disease, vascular disorder, arterial obstructive disease, cardiac diseases, heart diseases, cardiac disorders, cardiac disorder, heart disorder, disease, coronary, coronary heart diseases, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders, vascular disease, vasculopathy, vasc
Treatment Coronary Computed Tomography Angiography
Clinical Study IdentifierNCT04142021
SponsorNational University of Ireland, Galway, Ireland
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Occlusions or Vascular Diseases or Myocardial Ischemia or Ischemic Heart Disease or Coronary heart disease or Cardiac Ischemia or Cardiac Disease or A...?
Do you have any of these conditions: Coronary Artery Disease or Ischemic Heart Disease or Coronary heart disease or coronary disease or cardiovascular diseases or Heart disease or cardiov...?
Patients referred to CABG treatment (as assessed by 'conventional heart team') having at the time of the conventional heart team evaluation at least 1 de novo stenotic lesion (with a visually assessed DS with 50%) in all 3 major epicardial territories [left anterior descending (LAD) and/or side branch, left circumflex artery (LCX) and/or side branch, right coronary artery (RCA) and/or side branch] supplying viable myocardium with or without left main involvement
Patients with hypoplastic RCA with absence of descending posterior and presence of a lesion in the LAD and LCX territories may be included in the trial as a 3VD equivalent. Ostial LAD plus ostial LCX may be included in the trial as a left main equivalent
Distal vessel size should be at least 1.5 mm in diameter as visually assessed in the diagnostic angiogram (as requested by the surgeons)
Patients with silent ischemia, chronic coronary syndrome or stabilized acute coronary syndrome with normalized (stable or decreasing) cardiac biomarker values. For patients showing elevated troponin (cTn) (e.g. non-ST elevation myocardial infarction [NSTEMI] patients) at baseline (within 24h pre-CABG) an additional blood sample must be collected prior to CABG to confirm that: a) hs-cTn or troponin I or T levels are stable, i.e. the value should be within 20% range of the value found in the first sample at baseline, or have dropped 25; b) creatine kinase-muscle/brain (CK-MB) and creatine kinase (CK) levels are within normal range. If hs-cTn or troponin I or T levels are stable or have dropped, or the CK-MB and CK levels are within normal ranges and the ECG is normal, patients may be included in the study
All anatomical SYNTAX Scores are eligible
Patients are amenable to coronary CTA (e.g. no claustrophobia, high heart rate not amenable to beta-blockers, poor renal function, etc., up to the discretion of the investigator)
Patients have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the Ethical Committee of the respective clinical site
Patients agree to 1-month follow-up visit including coronary CTA

Exclusion Criteria

Under the age of 18 years
Unable to give informed consent
Known pregnancy at the time of enrollment; female of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause); female who is breastfeeding at time of enrollment
Prior PCI or CABG; history of coronary stent implantation
Evidence of evolving or ongoing ST-elevation MI (STEMI) on ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of enrollment (non-STEMI)
Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance 30 mL/min), or need for dialysis, or acute kidney failure (as per physician judgment)
Concomitant cardiac valve disease requiring surgical therapy (repair or replacement) and/or aneurysmectomy
Single or two-vessel disease (at time of the conventional heart team consensus)
Non-graftable distal bed in >1 vessel as assessed by the surgeon based on ICA
Persistent atrial fibrillation or significant arrhythmias
Known allergy to iodinated contrast
A body mass index (BMI) of 35 or greater
Currently participating in another clinical trial not yet at its primary endpoint
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