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

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ClinicalTrials.gov Identifier: NCT03438448
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.


Condition or disease Intervention/treatment
Myocardial Ischemia Myocardial Injury Morality Other: High sensitive Troponin T monitoring

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Perioperative Myocardial Ischemia: Implementation of Troponin Monitoring, Economic Analysis and Further Insights Into Pathophysiology
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: High sensitive Troponin T monitoring
    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.


Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 1 month and 1 year after surgery ]
    Occurence of all cause mortality


Secondary Outcome Measures :
  1. Major adverse cardiac events (MACE) [ Time Frame: 1 month and 1 year after surgery ]
    Occurrence of MACE: myocardial infarction, unstable angina, congestive heart failure, new atrial fibrillation, stroke or pulmonary embolism

  2. Medication modifications [ Time Frame: 1 month and 1 year after surgery ]
    Starting new medication or modifying dose



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Ages Eligible for Study:   45 Years to 98 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion criteria:

  • 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).

Exclusion criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438448


Contacts
Contact: Ekaterine Popova, MD +34 93 5537808 ext 8057 epopova@santpau.cat

Locations
Spain
HospitalSCSP Recruiting
Barcelona, Spain, 08025
Contact: Ekaterine Popova, MD         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Pablo Alonso-Coello, MD, PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03438448     History of Changes
Other Study ID Numbers: IIBSP-IMP-2015-95
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Ultrasensitive Troponin T
MINS
Cost-effectiveness
Myocardial Ischemia

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases