Evaluation of the effect of crocin on prevention of atrial fibrillation after heart surgery

Phase 2

Recruiting

• Conditions: Atrial fibrillation after heart surgery.; Paroxysmal atrial fibrillation; I48.0

• Registration Number: IRCT20120520009801N4
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Candidates for heart surgery including CABG or valve replacement
70 yr > age > 18 yr
Taking ACEIs/ARBs, beta-blockers, statins and aspirin for CABG patients

Exclusion Criteria

Have pacemaker
Renal failure (45 = GFR)
Hepatic failure (hepatic enzymes > 3 times of upper normal limit )
Sensitivity to crocin or saffron
History of taking anti-inflammatory or anti-oxidant drugs via two weeks before surgery
Thyroid dysfunction
Have AF rhythm
History of heart surgery
Pregnancy and lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of atrial fibrillation. Timepoint: Through 72 hrs after heart surgery. Method of measurement: Holter monitoring.

Secondary Outcome Measures

Name	Time	Method
Hs-CRP blood concentration. Timepoint: Before surgery and 3 days after surgery. Method of measurement: Laboratory.;Oxidative stress. Timepoint: Before surgery and 3 days after surgery. Method of measurement: Laboratory - malondialdehyde assay.;The incidence of ventricular and supra-ventricular arrhythmias. Timepoint: Through 72 hrs after heart surgery. Method of measurement: Holter monitoring.;Lenght of hospital stay. Timepoint: From heart surgery to discharge. Method of measurement: Counting of hospitalizations days.