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Carotid Artery StenosisTROPICARNCT05293067

Troponin In Carotid Revascularization

An observational study of Carotid Artery Stenosis, run by University of Belgrade at 1 site in Serbia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Carotid Artery Stenosis
What is being tested?
high-sensitive troponin
How many people
527 participants
Where
1 siteSerbia
Study dates
1 Jun 2023to 1 Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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;

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

1 site in 1 country.

Serbia1 site
  • Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia

    Belgrade, Serbia, 11000

Other trials in Serbia

About this study

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?".

Read the detailed description

The aims of the study are: 1) to determine the incidence of elevated troponin levels pre- and postoperatively in patients undergoing CEA/CAS; 2) to assess whether elevated troponin levels pre- and postoperatively can predict the occurrence of myocardial infarction and death in these patients; 3) to demonstrate whether routine pre- and postoperative troponin measurement is justified in all or only in a particular subpopulation of patients, and 4) to assess whether, in this regard, a difference between patients undergoing CEA and CAS procedures exists.

A prospective, multicenter cohort study would include approximately 240 consecutive patients undergoing CEA/CAS procedures, under the conditions of regional/general and local anesthesia, during the period from April, to August 2022. 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), in whom concomitant or "staged" cardiac surgery or vascular procedure is planned, who had an acute coronary event in the previous 3 months, patients undergoing multiple CEA/CAS during the study period, as well as those patients with conditions that may lead to increased troponin levels (end-stage kidney disease, sepsis, acute pericarditis and myocarditis, advanced heart failure, chemotherapy, systemic inflammatory diseases, and critical limb ischemia) would be excluded from the study. Using a pre-designed questionnaire, standard demographic and clinical data (related to comorbidities, chronic therapy, habits, previous surgery, and characteristics of carotid disease) would be collected. Intraoperative data (type of carotid intervention, type of anesthesia technique, and shunt placement), as well as data regarding the postoperative course, would be obtained from the database implemented in daily practice and patients' medical records. High-sensitive troponin would be measured in all patients, according to the following plan: 1) preoperatively - one day before the planned intervention and 2) postoperatively - 8 hours after the operation and on the first day after the operation. Troponin samples would be frozen and analyzed only after the patient's hospital discharge. Also, ECG would be recorded immediately following troponin measurement (a day before the planned intervention, 8 hours and 24 hours after the intervention). Patients operated on at the Clinic for Vascular and Endovascular Surgery of the University Clinical Center of Serbia would be operated under the conditions of regional anesthesia - a combination of deep and superficial cervical plexus block (which is a regular practice at this Institution), or local infiltrative anesthesia (for CAS procedures), while patients in other Hospital would be treated under the conditions of general anesthesia (Collaborators - to be defined). Clinical outcomes of interest: myocardial injury, myocardial infarction, stroke, cardiac-related death, and the all-cause mortality, would be recorded perioperatively, until hospital discharge (2 days following the procedure). Myocardial infarction, stroke, cardiac-related death, and the all-cause mortality would be recorded preoperatively and up to 2 days following the procedure, one month after, one and two years following surgery (at regular postoperative check-ups or by telephone interview with the patient, or a member of his family). 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. In accordance with the same recommendations, acute myocardial infarction would be defined as the existence of an increase and/or decrease in troponin levels and clinical signs of acute myocardial ischemia. The indication for surgery or stenting procedure would be made based on the European Society of Vascular Surgery guidelines.

Following Institutional Ethics Committee approval (Approval No. 455/39, dated 07 May 2026), the follow-up period for study participants was extended from 2 years to 5 years. No other protocol changes were made.

Being tested
high-sensitive troponin
Medical subject headings
Carotid Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high-sensitive troponinDiagnostic 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.

Study groups in NCT05293067
Study groupRoleWhat they receive
carotid endarterectomyHigh-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.
Receives: Diagnostic Test: high-sensitive troponin
carotid artery stentingHigh-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.
Receives: Diagnostic Test: high-sensitive troponin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: preoperatively

  2. 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.

    Measured: 2 days following surgery

  3. 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.

    Measured: 2nd postoperative day

  4. 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.

    Measured: 2 years following surgery

  5. The rate of cardiac-related death

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

    Measured: 2nd postoperative day

  6. The rate of cardiac-related death

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

    Measured: 2 years following surgery

  7. 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.

    Measured: 2nd postoperative day

  8. 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.

    Measured: 2 years following surgery

  9. 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.

    Measured: 2nd postoperative day

  10. 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.

    Measured: 2 years following surgery

  11. 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.

    Measured: 5 years following surgery

  12. The rate of cardiac-related death

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

    Measured: 5 years following surgery

  13. 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.

    Measured: 5 years following surgery

  14. 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.

    Measured: 5 years following surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2022
  2. Study start1 Jun 2023
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
527 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05293067
Sponsor's protocol ID
TROPICAR
Acronym
TROPICAR
Status last verified
Jun 2026
First submitted
4 Mar 2022
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26553374
  • 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.

    PubMed 25601178
  • 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.

    PubMed 31542388
  • 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.

    PubMed 33427096

Questions about this trial

What is this clinical trial studying?

An observational study of Carotid Artery Stenosis, run by University of Belgrade at 1 site in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of myocardial injury (time frame: preoperatively). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05293067, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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