A Project to Improve the Diagnosis and Prognosis of Myocardial Injury Associated to Non Cardiac Surgery

Parc de Salut Mar

Status: Completed

Conditions: Myocardium; Injury

Treatments: Drug: Statin; Drug: Acetylsalicylic acid; Diagnostic Test: Troponin

Study type: Observational

Funder types: Other

Identifiers

NCT03133260

MINSMAR

Details and patient eligibility

About

Major adverse cardiovascular events are the leading cause of perioperative morbimortality in non-cardiac surgery. Perioperative myocardial infarction is usually asymptomatic, with a mortality around 10-12%.

Myocardial Injury in Noncardiac Surgery (MINS), is defined as a myocardial injury that provokes a troponin increase due to myocardial ischemia. MINS is a predictor of morbimortality at short term and at long term.

The aim of the study is to improve the diagnosis of myocardial injury after non cardiac surgery in high-risk patients, improve its treatment in case of MINS and establish prevention strategies.

Enrollment: 800 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both genders over 45 years scheduled for non-urgent surgery with in-hospital stay of 24 hours minimum who require general and or regional anaesthesia (epidural or subarachnoidal) that have signed the inform consent who will be operated of:

  1. High-risk surgery:

• Open abdominal aortic aneurism repair

• Major vascular surgery

• Major amputations

• Carotid endarterectomy

• Duodeno-pancreatic surgery

• Hepatic resection or resection of biliary duct

• Esophagectomy

• Suprarenal resection

• Cystectomy

• Pneumonectomy

  2. Medium risk-surgery with cardiovascular risk factors (see below):

• Intraperitoneal surgery (rectum, colon, small bowel, gastric surgery)

• Peripherical angioplasty

• Endovascular aneurism repair

• Head and neck surgery

• Major orthopedic surgery (hip, knee, column)

• Major urological or gynecological surgery

• Thoracic surgery (lobectomy or atypical pulmonary resections)

  a) With 1 risk factor:

• History of coronary artery disease

• History of cerebrovascular disease (history of transient ischemic attack or stroke)

• History of congestive heart failure

• History of vascular disease

  b) With 2 risk factors:

• Diabetes mellitus with medical treatment

• Renal disease (FGE < 45 ml•min-1•1.73m2 )

• Functional capacity < 4METs

• Intraoperative blood loss >600ml

Exclusion criteria

• Patients without consent information
• Patients non included in the inclusion criteria

Trial design

800 participants in 1 patient group

Non cardiac surgery

Description:

Determine perioperative troponin to diagnose perioperative MINS. In case of MINS acetylsalicylic acid and statins will be started if no contraindication. We will follow-up these patients for a year (including cardiologic evaluation after discharge)

Treatment:

Drug: Statin

Diagnostic Test: Troponin

Drug: Acetylsalicylic acid