Clinical trial NCT03133260: A Project to Improve the Diagnosis and Prognosis of Myocardial Injury Associated to Non Cardiac Surgery
Official title: A Project to Improve the Diagnosis and Prognosis of Myocardial Injury Associated to Non Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardium; Injury
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 800
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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) for high-risk surgery or middle risk-surgery with cardiovascular risk factors.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of myocardial injury after non cardiac surgery (MINS).
timeFrame: From the day of surgery until the third postoperative day
Secondary outcomes:
measure: Percentage of MINS which corresponds to myocardial infarction
timeFrame: From the day of surgery until the third postoperative day
measure: Morbimortality in high-risk surgery patients until hospital discharge
timeFrame: From the day of surgery until hospital discharge or until 30 days after surgery in case the patient still hospitalized
measure: Compare the prognosis of patients with MINS versus patients who present a myocardial infarction versus who presented non of them.
timeFrame: From the day of surgery until 1 year after surgery
measure: Morbimortality in high-risk surgery patients 30 days after surgery
timeFrame: From the day of surgery until 30 days after surgery
measure: Morbimortality in high-risk surgery patients 6 months after surgery
timeFrame: From the day of surgery until 6 months after surgery
measure: Long term morbimortality in high-risk surgery patients
timeFrame: From the day of surgery until 1 year after surgery
Other outcomes:
measure: Analysis and validation of risk predictors for perioperative major adverse cardiovascular events.
timeFrame: From the day of surgery until 1 year after surgery
Locations:
city: Barcelona
country: Spain
facility: Hospital Del Mar
Study officials:
affiliation: Anesthetist
name: Sandra Beltran, MD
role: PRINCIPAL_INVESTIGATOR
References: