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

Myocardium; Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133260
• Other study ID #: MINSMAR
• Status: Completed
• Start date: May 2, 2017
• Est. completion date: October 15, 2021

Study information

• Verified date: March 2022
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: October 15, 2021
• Est. primary completion date: April 30, 2019
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myocardium; Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• Troponin
Troponin will be measured before surgery and postoperative at days 1,2 and 3.

Drug:
• 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
• 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

Locations

Country	Name	City	State
Spain	Hospital Del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analysis and validation of risk predictors for perioperative major adverse cardiovascular events.	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	From the day of surgery until 1 year after surgery
Primary	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	Percentage of MINS which corresponds to myocardial infarction	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.	From the day of surgery until the third postoperative day
Secondary	Morbimortality in high-risk surgery patients until hospital discharge	Analyze morbimortality at hospital discharge of all patients included in the study.	From the day of surgery until hospital discharge or until 30 days after surgery in case the patient still hospitalized
Secondary	Compare the prognosis of patients with MINS versus patients who present a myocardial infarction versus who presented non of them.	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.	From the day of surgery until 1 year after surgery
Secondary	Morbimortality in high-risk surgery patients 30 days after surgery	Analyze morbimortality at 30 days of all patients included in the study	From the day of surgery until 30 days after surgery
Secondary	Morbimortality in high-risk surgery patients 6 months after surgery	Analyze morbimortality at 6 postoperative months of all patients included in the study	From the day of surgery until 6 months after surgery
Secondary	Long term morbimortality in high-risk surgery patients	Analyze morbimortality of all patients included in the study 1 year after surgery	From the day of surgery until 1 year after surgery