clinical trial metoprolol vs. placebo in patients about to undergo in non cardiac surgery and have moderate or high risk of perioperative cardiac effects (PeriOperative ISchemic Evaluation study)

• Conditions: patients with moderate or high cardiovascular risk (atherosclerotic disease, coronary disease) undergoing in non cardiac surgery; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2004-003595-11-ES
• Lead Sponsor: Asociación Colaboración Cochrane Iberoamericana (ACCIb)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-08
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients are eligible if they are undergoing non cardiac surgery; age > 45 years, have an expected length of hospital stay > 24 hours for surgical reasons, AND fulfill any one of the following six criteria: history of coronary artery disease, peripheral vascular disease, history of stroke thought due to atherothrombotic disease, hospitalization for congestive heart failure within 3 years of randomization, undergoing major vascular surgery OR fulfill any 3 of the following 7 risk factors: undergoing high-risk type surgery (intrathoracic, intraperitoneal), any history of congestive heart failure, diabetes and currently on an oral hypoglycemic agent or insulin therapy, pre-operative serum creatinine > 175 µmol/L (>2.0 mg/dl), age > 70 years, history of transient ischemic attack, undergoing emergency/urgent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

Contraindication to metoprolol including any of the following: significant bradycardia (heart rate < 50 beats per minute); second or third degree heart block without a pacemaker; asthma that has been active within the last decade (i.e. a clinical diagnosis of asthma and use of regular inhaled steroids, or beta agonists at least once per week over the period of a month, any time in the last ten years); and a history of COPD with bronchospasm on pulmonary function tests (i.e. an increase in FEV1 > 12% and of at least 200 ml, 15 minutes after inhalation of a beta 2 – agonist). Clinical plan to use a beta-blocker preoperatively or during the first 30 postoperative days Prior adverse reaction to a beta-blocker CABG surgery with complete revascularization in the preceding 5 years and no evidence of cardiac ischemia since the CABG surgery Patients undergoing low risk surgical procedures (e.g. transurethral procedures [transurethral prostatectomies (TURPs), stone baskets, etc], ophthalmologic procedures under topical or regional anesthesia [cornea transplants, cataract surgery, etc], and surgeries with limited physiological stresses [digital re-implantation, nerve repairs, etc] ) Concurrent use of verapamil; OR Prior enrollment in this trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified