Troponin in Carotid Revascularization

NCT05293067 | Active Not Recruiting DMC

• 1 other identifier: TROPICAR
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing carotid revascularization procedures are at increased risk for the development of short- and long-term cardiac complications. Increased values of high-sensitive troponin may be useful in a timely selection of those patients. Still, contemporary literature doesn't provide enough data to answer the following questions: "Can high-sensitive troponin predict adverse cardiac outcomes perioperatively in carotid surgery?", "Should these cardiac biomarkers be routinely sampled in all patients undergoing carotid revascularization?" and "Can elevated levels of high-sensitive troponin preoperatively designate patients in whom the risk of surgical treatment (at a given moment) is greater than the benefit of the surgery?".

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (10)

• The incidence of myocardial injury

  Myocardial injury would be defined in accordance with the current Fourth Universal Definition of Myocardial Infarction, published by the European Society of Cardiology, as the existence of at least one elevated troponin value above the 99th percentile of the upper reference limit.

  preoperatively

• The incidence of myocardial injury

  Myocardial injury would be defined in accordance with the current Fourth Universal Definition of Myocardial Infarction, published by the European Society of Cardiology, as the existence of at least one elevated troponin value above the 99th percentile of the upper reference limit.

  2 days following surgery

• The incidence of myocardial infarction

  Myocardial infarction would be defined as the existence of an increase and/or decrease in troponin levels and clinical signs of acute myocardial ischemia, in accordance with the Fourth Universal Definition of Myocardial Infarction.

  2nd postoperative day

• The incidence of myocardial infarction

  Myocardial infarction would be defined as the existence of an increase and/or decrease in troponin levels and clinical signs of acute myocardial ischemia, in accordance with the Fourth Universal Definition of Myocardial Infarction.

  2 years following surgery

• The rate of cardiac-related death

  Cardiac-related death would be defined as any lethal outcome that resulted due to progression of heart disease.

  2nd postoperative day

• The rate of cardiac-related death

  Cardiac-related death would be defined as any lethal outcome that resulted due to progression of heart disease.

  2 years following surgery

• The incidence of stroke

  Stroke would be defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin, with the evidence of acute infarction on brain computed tomography or magnetic resonance imaging.

  2nd postoperative day

• The incidence of stroke

  Stroke would be defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin, with the evidence of acute infarction on brain computed tomography or magnetic resonance imaging.

  2 years following surgery

• The rate of all-cause mortality

  All-cause mortality would refer to any lethal outcome (due to any cause), that would occur during the study.

  2nd postoperative day

• The rate of all-cause mortality

  All-cause mortality would refer to any lethal outcome (due to any cause), that would occur during the study.

  2 years following surgery

Study Arms (2)

carotid endarterectomy

High-sensitive troponin would be measured in patients undergoing carotid endarterectomy (CEA). Patients would be followed during the immediate postoperative period (until discharge from hospital), one month after, one and two years following the surgery, when researchers will gather information regarding the study outcomes during a regular postoperative control, or through telephone interviews.

Diagnostic Test: high-sensitive troponin

carotid artery stenting

High-sensitive troponin would be measured in patients undergoing carotid artery stenting (CAS). Patients would be followed in the immediate postoperative period (until discharge from hospital), one month after, one and two years following the surgery, when researchers will gather information regarding the study outcomes during a regular postoperative control, or through telephone interviews.

Diagnostic Test: high-sensitive troponin

Interventions

high-sensitive troponin DIAGNOSTIC_TEST

Values of high-sensitive troponin would be measured as follows: 1) preoperatively - one day before the planned intervention and 2) postoperatively - 8 hours after the operation and the first day after the operation.

carotid artery stenting; carotid endarterectomy

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with extracranial carotid stenosis greater than 50% (NASCET) in the carotid bifurcation or internal carotid artery assessed by ultrasound in whom carotid revascularisation is planned;

You may qualify if:

• Extracranial carotid stenosis greater than 50% (NASCET) in the carotid bifurcation or internal carotid artery assessed by ultrasound in whom carotid revascularisation is planned;
• The ability of the patient for follow-up examinations;
• Personally signed informed consent

You may not qualify if:

• Patients admitted due to emergency procedure for immediate surgical treatment (the same day);
• Patients with preoperative anemia (due to any reason, hemoglobin level \< 10 g/dL);
• Patients in whom concomitant or "staged" cardiac surgery or vascular procedure is planned,
• Patients who had an acute coronary event in the previous 3 months;
• Patients undergoing multiple CEA/CAS during the study period;
• Patients with end-stage kidney disease;
• Patients with sepsis:
• Patients with acute pericarditis/myocarditis;
• Patients with advanced heart failure;
• Patients on chemotherapy,
• Patients with systemic inflammatory diseases;
• Patients with critical limb ischemia;

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia

Belgrade, Serbia, 11000, Serbia

Location

Related Publications (4)

• Grobben RB, Vrijenhoek JE, Nathoe HM, Den Ruijter HM, van Waes JA, Peelen LM, van Klei WA, de Borst GJ. Clinical Relevance of Cardiac Troponin Assessment in Patients Undergoing Carotid Endarterectomy. Eur J Vasc Endovasc Surg. 2016 Apr;51(4):473-80. doi: 10.1016/j.ejvs.2015.09.023. Epub 2015 Nov 6.

  PMID: 26553374 BACKGROUND

• Galyfos G, Tsioufis C, Theodorou D, Katsaragakis S, Zografos G, Filis K. Cardiac troponin I after carotid endarterectomy in different cardiac risk patients. J Stroke Cerebrovasc Dis. 2015 Mar;24(3):711-7. doi: 10.1016/j.jstrokecerebrovasdis.2014.11.024. Epub 2015 Jan 16.

  PMID: 25601178 BACKGROUND

• Pereira-Macedo J, Rocha-Neves JP, Dias-Neto MF, Andrade JPV. Prognostic effect of troponin elevation in patients undergoing carotid endarterectomy with regional anesthesia - A prospective study. Int J Surg. 2019 Nov;71:66-71. doi: 10.1016/j.ijsu.2019.09.015. Epub 2019 Sep 19.

  PMID: 31542388 BACKGROUND

• Nagy B, Engblom E, Matas M, Maroti P, Koszegi T, Menyhei G, Lantos J, Szabo P, Molnar T. Increased serum level of high sensitivity troponin T even prior to surgery can predict adverse events during carotid endarterectomy. Vascular. 2021 Dec;29(6):938-944. doi: 10.1177/1708538120986297. Epub 2021 Jan 11.

  PMID: 33427096 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A peripheral venous blood sample would be taken from all of the study participants in order to determine values of high-sensitive troponin. Troponin samples would be frozen and analyzed only after the patient's hospital discharge.

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Igor Koncar, MD, Ph.D.

  University of Belgrade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular surgeon, MD, Ph.D.

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 24, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

SE (1)