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NCT Number: NCT03133260

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

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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Key information

Conditions

Myocardium; Injury Wounds and Injuries

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Del Mar

Barcelona, 08003, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • 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

Treatment and study plan

Troponin

Diagnostic Test

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

acetylsalicylic acid

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

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

Primary outcomes

  1. Prevalence of myocardial injury after non cardiac surgery (MINS).

    Time frame: From the day of surgery until the third postoperative day

    The aim of the study is to know the prevalence of myocardial injury after non cardiac surgery in high-risk surgical patients. The investigators will perform seriated troponin on the first 3 postoperative days, if troponin value are 30ng/L or more, the investigators will evaluate if troponin increase is due to cardiac or non-cardiac etiology (patients with TEP or sepsis will be excluded). Once the non-cardiac etiology is ruled out, it will be diagnosed of MINS

Secondary outcomes

  1. Percentage of MINS which corresponds to myocardial infarction

    Time frame: From the day of surgery until the third postoperative day

    Evaluate the percentage of MINS that corresponds to myocardial infarction. In all patients with the diagnosis of MINS the investigators will perform an ECG to evaluate ischemic changes, an echocardiogram to evaluate dyskinesias or akinesia or the presence of ischemic symptoms. If any of them are present, the investigators will diagnose the patient of acute myocardial infarction. So the investigators will compare number of patients who present a MINS with and without myocardial infarction.

  2. Morbimortality in high-risk surgery patients until hospital discharge

    Time frame: From the day of surgery until hospital discharge or until 30 days after surgery in case the patient still hospitalized

    Analyze morbimortality at hospital discharge of all patients included in the study.

  3. Compare the prognosis of patients with MINS versus patients who present a myocardial infarction versus who presented non of them.

    Time frame: From the day of surgery until 1 year after surgery

    To compare short and long term prognosis (hospital discharge, 30 days, 6 months and 1 year after surgery) of patients who presented MINS vs patients who presented myocardial infarction vs patients who did not presented any of them. The investigators will evaluate major cardiovascular events, non-cardiovascular complications and cardiac and all cause mortality.

  4. Morbimortality in high-risk surgery patients 30 days after surgery

    Time frame: From the day of surgery until 30 days after surgery

    Analyze morbimortality at 30 days of all patients included in the study

  5. Morbimortality in high-risk surgery patients 6 months after surgery

    Time frame: From the day of surgery until 6 months after surgery

    Analyze morbimortality at 6 postoperative months of all patients included in the study

  6. Long term morbimortality in high-risk surgery patients

    Time frame: From the day of surgery until 1 year after surgery

    Analyze morbimortality of all patients included in the study 1 year after surgery

Other outcomes

  1. Analysis and validation of risk predictors for perioperative major adverse cardiovascular events.

    Time frame: From the day of surgery until 1 year after surgery

    Analyse clinical risk factors for MINS, compare current MACCE clinical risk scores as predictors of MINS and develop a new score for prediction of MINS

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Apr 28, 2017
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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