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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-02

Study Completion Date

2021-10-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Myocardium; Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non cardiac surgery

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)

Troponin

Intervention Type DIAGNOSTIC_TEST

Troponin will be measured before surgery and postoperative at days 1,2 and 3.

Acetylsalicylic acid

Intervention Type DRUG

100mg acetylsalicylic acid will be started in case of MINS if no contraindication, it will be continued after hospital discharge. We will evaluate cardiovascular complications till 1 year after surgery

Statin

Intervention Type DRUG

40mg atorvastatin will be started in case of MINS if no contraindication, it will be continued after hospital discharge. We will evaluate cardiovascular complications till 1 year after surgery

Interventions

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Troponin

Troponin will be measured before surgery and postoperative at days 1,2 and 3.

Intervention Type DIAGNOSTIC_TEST

Acetylsalicylic acid

100mg acetylsalicylic acid will be started in case of MINS if no contraindication, it will be continued after hospital discharge. We will evaluate cardiovascular complications till 1 year after surgery

Intervention Type DRUG

Statin

40mg atorvastatin will be started in case of MINS if no contraindication, it will be continued after hospital discharge. We will evaluate cardiovascular complications till 1 year after surgery

Intervention Type DRUG

Eligibility Criteria

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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