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

NCT03133260 | Completed

• 1 other identifier: MINSMAR
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardium; Injury

Outcome Measures

Primary Outcomes (1)

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

  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

  From the day of surgery until the third postoperative day

Secondary Outcomes (6)

• Percentage of MINS which corresponds to myocardial infarction

  From the day of surgery until the third postoperative day

• Morbimortality in high-risk surgery patients until hospital discharge

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

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

  From the day of surgery until 1 year after surgery

• Morbimortality in high-risk surgery patients 30 days after surgery

  From the day of surgery until 30 days after surgery

• Morbimortality in high-risk surgery patients 6 months after surgery

  From the day of surgery until 6 months after surgery

Other Outcomes (1)

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

  From the day of surgery until 1 year after surgery

Study Arms (1)

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)

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

Interventions

Troponin DIAGNOSTIC_TEST

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

Non cardiac surgery

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

Non cardiac 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

Non cardiac surgery

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients without consent information

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital Del Mar

Barcelona, 08003, Spain

Location

Related Publications (1)

• Mases A, Beltran de Heredia S, Gallart L, Roman L, Bosch L, Nunez M, Rueda M, Recasens L, Sabate S. Prediction of Acute Myocardial Injury in Noncardiac Surgery in Patients at Risk for Major Adverse Cardiovascular and Cerebrovascular Events: A Multivariable Risk Model. Anesth Analg. 2023 Dec 1;137(6):1116-1126. doi: 10.1213/ANE.0000000000006469. Epub 2023 Apr 12.

  PMID: 37043386 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Aspirin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Sandra Beltran, MD

  Anesthetist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologyst deputy, MD.

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 28, 2017
• Study Start: May 2, 2017
• Primary Completion: April 30, 2019
• Study Completion: October 15, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)