Study: NCT05632432

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Epicardial AAMs-patch transplantation
Description: Perioperative assembly of an AAMs-patch with epicardial transplantation onto the epicardium of the scarred myocardium at the end of CABG surgery

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: RNA-stabilized whole blood sampling
Description: Collection (preoperative and at 6-month-follow-up) of TEMPUS(TM) stabilizing whole blood for epitranscriptomics-oriented measurements

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: RNA-stabilized whole blood sampling
Description: Collection (preoperative and at 6-month-follow-up) of TEMPUS(TM) stabilizing whole blood for epitranscriptomics-oriented measurements

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Plasma sampling
Description: Collection (preoperative and at 6-month follow-up) of blood-derived both RNA-stabilized and non-stabilized plasma aliquots for epitranscriptomic-oriented and other CVD biomarker oriented measurements, respectively

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Plasma sampling
Description: Collection (preoperative and at 6-month follow-up) of blood-derived both RNA-stabilized and non-stabilized plasma aliquots for epitranscriptomic-oriented and other CVD biomarker oriented measurements, respectively

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Transthoracic echocardiography
Description: To assess cardiac structure and function both pre- and postoperatively (at both hospital discharge and 3-month follow-up)

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Transthoracic echocardiography
Description: To assess cardiac structure and function both pre- and postoperatively (at both hospital discharge and 3-month follow-up)

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Late-gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI)
Description: To assess detailed cardiac structure (i.e. interstitial fibrosis) and function both preoperatively and at 6-month follow-up postoperatively.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Late-gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI)
Description: To assess detailed cardiac structure (i.e. interstitial fibrosis) and function both preoperatively and at 6-month follow-up postoperatively.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Symptom-scaling
Description: Standardised evaluation of IHD and HF-related angina pectoris (CCS) and dyspnea (NYHA) and life quality (RAND36) pre- and postoperatively (at both 3- and 6-month follow-up).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Symptom-scaling
Description: Standardised evaluation of IHD and HF-related angina pectoris (CCS) and dyspnea (NYHA) and life quality (RAND36) pre- and postoperatively (at both 3- and 6-month follow-up).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: 6-minute walking test (6MWT)
Description: Standardised assessment of physcial capacity pre- and postoperatively (at 6-month follow-up)

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 6-minute walking test (6MWT)
Description: Standardised assessment of physcial capacity pre- and postoperatively (at 6-month follow-up)

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Blood sampling (NT-proBNP)
Description: Collection of a blood sample measurement of NT-proBNP by an accredited hospital laboratory pre- and postoperatively (at both 3- and 6-month follow-up).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Blood sampling (NT-proBNP)
Description: Collection of a blood sample measurement of NT-proBNP by an accredited hospital laboratory pre- and postoperatively (at both 3- and 6-month follow-up).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Transesophageal echocardiography
Description: Performed by the perfusion-anesthesiologist at the beginning of the CABG surgery to evaluate both LAA and RAA for blood flow velocities, anatomy, possible sludge and thrombus.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Transesophageal echocardiography
Description: Performed by the perfusion-anesthesiologist at the beginning of the CABG surgery to evaluate both LAA and RAA for blood flow velocities, anatomy, possible sludge and thrombus.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Epicardial collagen-based patch transplantation
Description: Epicardial transplantation of the collaged-based patch material without the AAMs onto the epicardium of the scarred myocardium at the end of CABG surgery.