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Protection During Cardiac Surgery. (ProCCard)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Cardiopulmonary Bypass
Thoracic Surgery

Treatments

Other: standard anesthetic procedure
Other: multimodal cardioprotection strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT03230136
69HCL17_0174

Details and patient eligibility

About

This trial investigates whether a multimodal cardioprotection per-surgery therapeutic strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to traditional management. The primary endpoint is the AUC (area under the curve) of the hypersensitive troponin I. Blood samples will be collected during the 72 hours following the aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.

Enrollment

210 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 18 years old
  • Aortic valve surgery (aortic valve replacement associated or not with coronary artery bypass graft, Bentall surgery or Tirone David surgery)
  • Signed informed consent

Exclusion criteria

  • Emergency surgery
  • Redo surgery
  • Patient treated with Nicorandil, repaglinid or sulfonylurea 48 hours prior to surgery
  • Low cardiac output requiring catecholamine infusion or circulatory assistance prior to surgery
  • Severe renal failure: dialysis or glomerular filtration rate < 30 mL/min
  • Severe liver failure (spontaneous INR >2)
  • Severe respiratory insufficiency (VEMS <40% of predicted value)
  • Contra-indication to sevoflurane and propofol
  • Myocardial infarction < 7 days
  • Severe upper limb arterial disease
  • Heparin-induced thrombopenia
  • Active infection under antibiotic treatment
  • Any other surgery combined with the aortic valve surgery: myotomia of Morrow (hypertrophic myocardiopathy), treatment of heart rhythm disorder, inter-atrial communication closure, mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement.
  • Pregnant women
  • Currently participating in another trial which may interfere with ProCCard results
  • Not benefiting from a social insurance or similar system
  • Patient under legal protection

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

210 participants in 2 patient groups

Multimodal cardioprotection therapeutic strategy
Experimental group
Treatment:
Other: multimodal cardioprotection strategy
Traditional anesthetic and therapeutic
Active Comparator group
Description:
standard anesthetic procedure No intervention (Control).
Treatment:
Other: standard anesthetic procedure

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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