High-sensitivity Troponin T in Acute Myocardial Infarction After Cardiac Valvular Surgery

NCT02518282 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2015-08-17

No results posted yet for this study

Summary

A measurable degree of heart muscle tissue injury is expected in patients undergoing heart valvular surgery. The level of this injury can be measured by cardiac biomarkers in blood samples. Those biomarkers are used to diagnose an acute myocardial infarction.

Postoperative myocardial infarction (MI) is a frequent and important complication after cardiac surgery with high morbidity and mortality. Therefore it is very important to recognize any cardiac event in patients who undergo cardiac surgery. Different diagnostic tools can be used to the diagnosis of acute myocardial infarction; however few is known about the value of high-sensitivity cardiac troponin T (hs-cTn) to diagnose a MI after heart valvular surgery.

The aim of this study is to determine the upper reference limit of high-sensitivity troponin T concentration to consider the diagnosis of acute myocardial infarction in patients undergoing heart valvular surgery.

Conditions

  • Acute Myocardial Infarction
  • Disorder; Heart, Functional, Postoperative, Cardiac Surgery
  • Myocardial Infarction
  • Heart Valve Diseases

Interventions

OTHER

Serum levels of high-sensitivity troponin T

Serum levels of hs-cTn will be measured before surgery, upon arrival at the ICU, as well as every 6 hours for 24 hours, then every 8 hours the following 24 hours and a last blood sample will be taken 72 hours after surgery.

OTHER

Twelve-lead ECGs

Twelve-lead ECGs obtained the day prior to heart valvular surgery, immediately upon arrival at the ICU, and then 24, 48 and 72 hours post-surgery will be reviewed by a cardiologist to evidence signs of MI.

OTHER

Transthoracic echocardiography (TTE)

A TTE will be also performed by a cardiologist after cardiac valvular surgery to determine the ejection fraction of left ventricle and the occurrence of a new regional wall motion abnormality. This TTE will be compared, by the same cardiologist, with a TTE performed before cardiac valvular surgery.

Sponsors & Collaborators

  • University of Valladolid

    lead OTHER

Principal Investigators

  • Héctor Cubero Gallego, MD · University Clinical Hospital of Valladolid

  • Eduardo Tamayo Gómez, MD, PhD · University Clinical Hospital of Valladolid

  • José Alberto San Román Calvar, MD, PhD · University Clinical Hospital of Valladolid

  • José Ignacio Gómez Herreras, MD, PhD · University Clinical Hospital of Valladolid

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02518282 on ClinicalTrials.gov