Thoracic SurgeryProCCardNCT03230136
Protection During Cardiac Surgery.
A study testing multimodal cardioprotection strategy and standard anesthetic procedure in people with Thoracic Surgery and Cardiopulmonary Bypass, run by Hospices Civils de Lyon at 8 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Cardiopulmonary Bypass
- What is being tested?
- multimodal cardioprotection strategy and standard anesthetic procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 8 sitesFrance
- Study dates
- 3 Jan 2018to 3 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CH Annecy
Annecy
Service d'Anesthésie-Réanimation, Hôpital Cardiologique et Pneumologique Louis Pradel
Bron, 69500
CHU de Caen
Caen
service de Chirurgie Cardiaque CHU Gabriel Montpied
Clermont-Ferrand
Unité de Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon
Grenoble
Clinique de la sauvegarde
Lyon
CHU Saint-Etienne
Saint-Etienne
Institut Arnault Tzanck - Saint-Laurent du Var
Saint-Laurent-du-Var
About this study
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.
- Conditions
- Thoracic Surgery, Cardiopulmonary Bypass
- Being tested
- multimodal cardioprotection strategy, standard anesthetic procedure
- Keywords
- Myocardial injury, Ischemia reperfusion, cardiac surgery, cardioprotection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal cardioprotection strategyOther
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).
standard anesthetic procedureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal cardioprotection therapeutic strategy | Experimental | Not described Receives: Other: multimodal cardioprotection strategy |
| Traditional anesthetic and therapeutic | Active comparator | standard anesthetic procedure No intervention (Control). Receives: Other: standard anesthetic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 72 hours
Secondary outcomes (11)
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
Measured: 30 days
Troponin I serum peak value
Highest serum value recorded for each patient within 72 hours
Measured: 72 hours
Troponin I serum value
Serum value recorded for each patient within 24 hours
Measured: 24 hours
Length of mechanical ventilation
Measured: 30 days
Length of stay in intensive care unit (ICU)
Measured: 30 days
Length of stay in hospital
Measured: 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).
Measured: 24 hours
Number of participants with catecholaminergic support
Measured: baseline and 30 days
Dose of catecholaminergic support
Measured: 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.
Measured: Baseline and 30 days
number of death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start3 Jan 2018
- Primary completion30 May 2019
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc FELLAHI, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230136
- Sponsor's protocol ID
- 69HCL17_0174
- Acronym
- ProCCard
- Status last verified
- Dec 2025
- First submitted
- 24 Jul 2017
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31511041Chiari 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.
PubMed 33573748
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection During Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT03230136
- Acronym / sponsor ID
- ProCCard / 69HCL17_0174
- Conditions
- Thoracic Surgery, Cardiopulmonary Bypass
- Keywords
- Myocardial injury, Ischemia reperfusion, cardiac surgery, cardioprotection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal cardioprotection therapeutic strategy | Experimental | Other: multimodal cardioprotection strategy |
| Traditional anesthetic and therapeutic | Active comparator | Other: standard anesthetic procedurestandard anesthetic procedure No intervention (Control). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimodal cardioprotection strategyMultimodal 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). | Other | Multimodal cardioprotection therapeutic strategy |
| standard anesthetic procedurestandard 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. | Other | Traditional anesthetic and therapeutic |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I
Time frame: at 72 hours
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.
11 secondary outcomes
Adverse events incidence during the first 30 days following surgery of the multimodal cardioprotection strategy
Time frame: 30 days
Troponin I serum peak value
Time frame: 72 hours
Troponin I serum value
Time frame: 24 hours
Length of mechanical ventilation
Time frame: 30 days
Length of stay in intensive care unit (ICU)
Time frame: 30 days
Length of stay in hospital
Time frame: 30 days
Index Gravity Score (IGS II, the scoring system measuring the severity of disease for patients admitted to ICU)
Time frame: 24 hours
Number of participants with catecholaminergic support
Time frame: baseline and 30 days
Dose of catecholaminergic support
Time frame: baseline and 30 days
3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Time frame: Baseline and 30 days
number of death
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 31511041Chiari 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.
- Results publication: PubMed 33573748Chiari 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.
Related trials for Thoracic Surgery
RecruitingObservational study
Sensory Anesthesia Achieved Through Different Paravertebral Block Approaches for Post-Op Pain Management After VATS Lung Resection
Thoracic Surgery, Video-assisted
RecruitingObservational study
Thoracic Surgery by SHURUI Single-Port Surgical Robot
Thoracic Surgery
Not yet recruitingObservational study
Preoperative Nutritional Status and Postoperative Outcomes in Geriatric Lung Resection
Thoracotomy, Toracosurgery
Recruiting
Telerehabilitation Exercise Program for Postoperative Recovery in Lung Cancer.
Lung Neoplasms, Thoracic Surgery Lung
Not yet recruitingPhase 4
Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer
Pneumococcal Polysaccharide Vaccine, Influenza Vaccines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc FELLAHI principal investigator
Hospices Civils de Lyon
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal cardioprotection strategy and standard anesthetic procedure in people with Thoracic Surgery and Cardiopulmonary Bypass, run by Hospices Civils de Lyon at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I (time frame: at 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03230136, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.