Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

Effects of Diltiazem and/or N-Acétylcystéine Versus Placebo on hémodynamiques and Biological Repercussions of the Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01771978

Enrollment

120

Registered

2013-01-18

Start date

2002-06-30

Completion date

Unknown

Last updated

2013-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemia-reperfusion Injury

Keywords

ischaemia-reperfusion injury, cardiac surgery, oxidative stress markers, troponin, diltiazem, acetylcystein

Brief summary

Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.

Interventions

DRUGPlacebo

Received 250 ml of a 5% dextrose solution as placebo

DRUGDiltiazem

Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution

DRUGAcetylcystein

Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution

DRUGdiltiazem and acetylcystein

Received a combination of drug :diltiazem and acetylcystein * bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution * 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age included between 60 and 80 years

Exclusion criteria

* Age \< 60 or \> 80 years * Pregnancy * The allergy in used medicines (N-acétylcystéine, Diltiazem) * Presence of a pathology valvulaire associated * Urgency * Unstable angor * Bypass as a matter of urgency * Recours peropératoire to a CEC * FE \< 0,40 * BAV of the 2nd and 3rd not sailed degree * fibrillation or flutter little finger.

Design outcomes

Primary

Measure	Time frame	Description
Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine	during ischaemia-reperfusion	Choosing as main biological variable rate cTnI cardiospecific, above the threshold of detection (0.3 mcg / L) in 40% of patients operated on a beating heart hoping to reduce this percentage to 10% as a result of treatment with diltiazem and N-acetylcysteine

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026