Protection During Cardiac Surgery. (ProCCard)

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.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Bypass; Thoracic Surgery
• Intervention / Treatment: Other: multimodal cardioprotection strategy; Other: standard anesthetic procedure

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Annecy, France
    • CH Annecy
  • Bron, France, 69500
    • Service d'Anesthésie-Réanimation, Hôpital Cardiologique et Pneumologique Louis Pradel
  • Caen, France
    • CHU de Caen
  • Clermont-Ferrand, France
    • service de Chirurgie Cardiaque CHU Gabriel Montpied
  • Grenoble, France
    • Unité de Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon
  • Lyon, France
    • Clinique de la Sauvegarde
  • Saint-Etienne, France
    • CHU Saint-Etienne
  • Saint-Laurent-du-Var, France
    • Institut Arnault Tzanck - Saint-Laurent du Var

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal cardioprotection therapeutic strategy	Other: multimodal cardioprotection strategy; Multimodal cardioprotection therapeutic strategy will include (1) remote ischemic preconditioning, (2) volatile anesthetic sevoflurane-induced preconditioning, (3) blood glucose control every 30 minutes during cardiac surgery, (4) temporary respiratory acidosis prior to the aortic cross-unclamping and (5) gradual restoration of blood flow after aortic cross-unclamping (gentle reperfusion).
Active Comparator: Traditional anesthetic and therapeutic; standard anesthetic procedure No intervention (Control).	Other: standard anesthetic procedure; standard anesthetic procedure will include: anesthesia under propofol throughout the cardiac surgery, blood glucose control every 60 minutes, arterial pH maintained at 7.40, theoric blood flow restored at the earliest after aortic cross-unclamping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I	Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I determined for each patient with the serial measurement from of troponin I assays.	at 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of mechanical ventilation		30 days
Length of stay in hospital		30 days
Adverse events incidence during the first 30 days following surgery of the multimodal cardioprotection strategy	Adverse events will include death, myocardial infarction, heart failure,arrhythmia requiring medical therapy, neurological disorder such as stroke,respiratory insufficiency, any infectious event, major bleeding requiring transfusion of ≥ 5 U packed red blood cells or surgical intervention or surgical complication	30 days
Troponin I serum peak value	Highest serum value recorded for each patient within 72 hours	72 hours
Troponin I serum value	Serum value recorded for each patient within 24 hours	24 hours
Length of stay in intensive care unit (ICU)		30 days
Index Gravity Score (IGS II, the scoring system measuring the severity of disease for patients admitted to ICU)	Index Gravity Score provides an estimate of the risk of death: the higher the score is, the higher the risk to die is. The maximum score is 163. The Index Gravity Score includes 17 variables: 12 physiology variables, age, type of admission (scheduled surgical, unscheduled surgical, or medical), and three underlying disease variables (acquired immunodeficiency syndrome, metastatic cancer, and hematologic malignancy).	24 hours
Number of participants with catecholaminergic support		baseline and 30 days
Dose of catecholaminergic support		baseline and 30 days
3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)	The 3-level version of EQ-5D consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.	Baseline and 30 days
number of death		30 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jean-Luc FELLAHI, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Chiari P, Durand M, Desebbe O, Fischer MO, Lena-Quintard D, Palao JC, Mercier C, Samson G, Varillon Y, Pozzi M, Mewton N, Maucort-Boulch D, Ovize M, Fellahi JL. Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial. Trials. 2019 Sep 11;20(1):560. doi: 10.1186/s13063-019-3638-3.
• Chiari P, Mewton N, Maucort-Boulch D, Desebbe O, Durand M, Fischer MO, Lena-Quintard D, Palao JC, Ovize M, Fellahi JL. Multimodal Strategy for Myocardial Protection During Cardiac Surgery: The ProCCard Study. J Am Coll Cardiol. 2021 Feb 16;77(6):827-829. doi: 10.1016/j.jacc.2020.12.020. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): July 3, 2019

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: cardiac surgery; cardioprotection; Myocardial injury; Ischemia reperfusion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 69HCL17_0174

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No