Perioperative Myocardial Ischemia: Troponin Monitoring,Cost-effectiveness, Insights Into Pathophysiology

NCT03438448 | Completed DMC

• 1 other identifier: IIBSP-IMP-2015-95
• Study Type: observational
• Target: 1,510
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Despite preoperative screening, technical improvements and increased patient monitoring, perioperative myocardial infarction (PMI) remains the first cause of morbidity and mortality within 30 days after surgery. Moreover, the available evidence indicates worrying rise of risk in postoperative patients with only elevated troponins reflecting cardiac injury, but without a conventional clinical diagnosis of myocardial infarction according to current definition. Worldwide, annually approximately 300 million adults undergo major non cardiac surgery and 10 million of them are estimated to suffer a myocardial injury after non-cardiac surgery (MINS), defined as a prognostically relevant increase of a troponin T peak of 0.03 ng/ml or greater. Many of the patients with MINS does not fulfill the universal definition of myocardial infarction, rarely experience ischemic symptoms and their prognosis is very poor (1 out of 10 die at 30 days).Troponin levels needed to be monitored in order to MINS diagnose and high sensitive cardiac troponin T assays are currently the most frequently used. Methods: Patients with high cardiovascular risk undergoing major non-cardiac surgery will be selected from the daily surgical program during a two years period Three determinations of hs-cTnT for each patient will be obtained. The proportion of patients with MINS and pre- and post-operative thresholds of hs-cTnT that would be prognostically relevant will be determined. The cost-effectiveness analysis of hs-cTnT monitoring compared with usual care will be undertaken. Finally using computed tomography angiography (CTA) and cardiac magnetic resonance imaging (MRI) pathophysiology of MINS will be determined, whether is due to plaque rupture, supply-demand mismatch, non-ischemic cardiac cause or non-cardiac cause. Discussion: The study will evaluate the feasibility and impact of implementing the hs-cTnT monitoring program in the Hospital de la Santa Creu i Sant Pau of Barcelona, as well as its cost-effectiveness. Moreover, this is the first study which will determine pre and postoperative thresholds of hs-cTnT and with minimally invasive diagnostic tools will evaluate potential mechanisms involved in perioperative ischemic events.

Conditions

Myocardial Ischemia; Myocardial Injury; Morality

Keywords

Ultrasensitive Troponin T; MINS; Cost-effectiveness; Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  Occurence of all cause mortality

  1 month and 1 year after surgery

Secondary Outcomes (2)

• Major adverse cardiac events (MACE)

  1 month and 1 year after surgery

• Medication modifications

  1 month and 1 year after surgery

Interventions

High sensitive Troponin T monitoring OTHER

Three determinations of Roche high-sensitive troponin T (99th percentile (14 ng/L) for each patient: preoperative (during the preoperative visit or just before surgery), 48h, and 72h after surgery. If a rise and/or fall of hs-cTnT with at least one value above the 99th percentile upper reference is detected, a clinical evaluation and a 12-lead ECG will be performed. If no ECG changes, ischemic symptoms, or pulmonary edema to fulfill the diagnostic for PMI the patients will undergo an echocardiographic study.

Eligibility Criteria

• Age: 45 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults ≥ 65 years or \< 65 years with documented cardiovascular disease (history of coronary artery disease, history of congestive heart disease, history of stroke, history of peripheral vascular disease) undergoing a major non-cardiac surgery can considered for eligibility. Eligible Patients will be approached for informed consent after surgery and before hospital discharge.

You may qualify if:

• Age ≥ 65 years.
• Age \< 65 years and documented cardiovascular disease (history of coronary artery disease, history of congestive heart disease, history of stroke, history of peripheral vascular disease).
• Renal insufficiency (GF \<60ml/min).

You may not qualify if:

• Patients undergoing non cardiac surgery that do not require an overnight hospital admission or that only receive infiltrative (i.e., local) or topical anesthesia.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

HospitalSCSP

Barcelona, 08025, Spain

Location

Related Publications (2)

• Alvarez-Garcia J, Popova E, Vives-Borras M, de Nadal M, Ordonez-Llanos J, Rivas-Lasarte M, Moustafa AH, Sole-Gonzalez E, Paniagua-Iglesias P, Garcia-Moll X, Vilades-Medel D, Leta-Petracca R, Oristrell G, Zamora J, Ferreira-Gonzalez I, Alonso-Coello P, Carreras-Costa F. Myocardial injury after major non-cardiac surgery evaluated with advanced cardiac imaging: a pilot study. BMC Cardiovasc Disord. 2023 Feb 10;23(1):78. doi: 10.1186/s12872-023-03065-6.

  PMID: 36765313 DERIVED

• Popova E, Alonso-Coello P, Alvarez-Garcia J, Paniagua-Iglesias P, Rue-Monne M, Vives-Borras M, Font-Gual A, Gich-Saladich I, Martinez-Bru C, Ordonez-Llanos J, Carles-Lavila M. Cost-effectiveness of a high-sensitivity cardiac troponin T systematic screening strategy compared with usual care to identify patients with peri-operative myocardial injury after major noncardiac surgery. Eur J Anaesthesiol. 2023 Mar 1;40(3):179-189. doi: 10.1097/EJA.0000000000001793. Epub 2023 Jan 11.

  PMID: 36722187 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Pablo Alonso-Coello, MD, PhD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 19, 2018
• Study Start: July 11, 2016
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2020
• Last Updated: January 12, 2022

Record last verified: 2022-01

Locations

ES (1)