NCT02518282

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

2.2 years

First QC Date

August 4, 2015

Last Update Submit

August 14, 2015

Conditions

Acute Myocardial InfarctionDisorder; Heart, Functional, Postoperative, Cardiac SurgeryMyocardial InfarctionHeart Valve Diseases

Keywords

high-sensitivity troponin TAcute myocardial infarctionHeart valvular surgeryCardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Determination of upper reference limit (URL) of high-sensitivity troponin T that strongly suggests substantial myocardial damage and necrosis.

    Postoperative MI remains a frequent complication after cardiac surgery with high morbidity and mortality. In 2012 the Third Global MI Task Force presented the third universal definition of MI implying that MI associated with coronary artery bypass grafting (CABG) is arbitrarily defined by elevation of cardiac biomarkers values over 10 x 99th percentile URL in patients with normal baseline cTn values. In addition with either: a) new pathological Q waves or new left bundle branch block (LBBB), or b) angiographic documented new graft or new native coronary artery occlusion, or c) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Few is known about the established threshold values for hs-cTn after heart valvular surgery.

    Every 6 postoperative hours for the first 24 hours, then every 8 hours the following 24 hours and a last sample will be taken 72 hours after heart valvular surgery.

Secondary Outcomes (2)

  • High-sensitivity troponin T concentration changes over time in patients undergoing heart valvular surgery

    From 8 hours preoperatively to 72 hours postoperatively

  • Number of patients with complications after heart valvular surgery.

    After cardiac valvular surgery to 72 hours post-surgery.

Other Outcomes (2)

  • Twelve-lead ECGs.

    The day prior to cardiac surgery, immediately upon arrival at the ICU, and then 24, 48 and 72 hours post-surgery.

  • Transthoracic Echocardiography (TTE).

    Before heart valvular surgery and after heart valvular surgery.

Interventions

Serum levels of high-sensitivity troponin TOTHER

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.

Twelve-lead ECGsOTHER

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.

Transthoracic echocardiography (TTE)OTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients (over 18 years old) undergoing heart valvular surgery with CPB.

You may qualify if:

  • Each participant must be older than 18 years.
  • Undergoing cardiac valvular surgery.
  • No recent clinical history of ischemic heart disease.
  • Each participant must voluntarily give his written informed consent.

You may not qualify if:

  • Patients undergoing coronary bypass artery grafting (CABG).
  • Patients with severe or end-stage renal insufficiency.
  • Insertion of assist devices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Hospital of Valladolid

Valladolid, Spain, 47005, Spain

RECRUITING

Related Publications (6)

  • Thygesen K, Mair J, Katus H, Plebani M, Venge P, Collinson P, Lindahl B, Giannitsis E, Hasin Y, Galvani M, Tubaro M, Alpert JS, Biasucci LM, Koenig W, Mueller C, Huber K, Hamm C, Jaffe AS; Study Group on Biomarkers in Cardiology of the ESC Working Group on Acute Cardiac Care. Recommendations for the use of cardiac troponin measurement in acute cardiac care. Eur Heart J. 2010 Sep;31(18):2197-204. doi: 10.1093/eurheartj/ehq251. Epub 2010 Aug 3.

    PMID: 20685679RESULT

  • Morrow DA, Cannon CP, Jesse RL, Newby LK, Ravkilde J, Storrow AB, Wu AH, Christenson RH, Apple FS, Francis G, Tang W; National Academy of Clinical Biochemistry. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: clinical characteristics and utilization of biochemical markers in acute coronary syndromes. Clin Chem. 2007 Apr;53(4):552-74. doi: 10.1373/clinchem.2006.084194. Epub 2007 Mar 23. No abstract available.

    PMID: 17384001RESULT

  • Wang TK, Stewart RA, Ramanathan T, Kang N, Gamble G, White HD. Diagnosis of MI after CABG with high-sensitivity troponin T and new ECG or echocardiogram changes: relationship with mortality and validation of the universal definition of MI. Eur Heart J Acute Cardiovasc Care. 2013 Dec;2(4):323-33. doi: 10.1177/2048872613496941. Epub 2013 Aug 5.

    PMID: 24338291RESULT

  • Lurati Buse GA, Koller MT, Grapow M, Bolliger D, Seeberger M, Filipovic M. The prognostic value of troponin release after adult cardiac surgery - a meta-analysis. Eur J Cardiothorac Surg. 2010 Feb;37(2):399-406. doi: 10.1016/j.ejcts.2009.05.054. Epub 2009 Aug 20.

    PMID: 19699102RESULT

  • Apple FS, Jesse RL, Newby LK, Wu AH, Christenson RH; National Academy of Clinical Biochemistry; IFCC Committee for Standardization of Markers of Cardiac Damage. National Academy of Clinical Biochemistry and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice Guidelines: Analytical issues for biochemical markers of acute coronary syndromes. Circulation. 2007 Apr 3;115(13):e352-5. doi: 10.1161/CIRCULATIONAHA.107.182881. Epub 2007 Mar 23. No abstract available.

    PMID: 17384332RESULT

  • Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. Third universal definition of myocardial infarction. Glob Heart. 2012 Dec;7(4):275-95. doi: 10.1016/j.gheart.2012.08.001. Epub 2012 Sep 26. No abstract available.

    PMID: 25689940RESULT

MeSH Terms

Conditions

Myocardial InfarctionHeart Valve Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Héctor Cubero Gallego, MD

    University Clinical Hospital of Valladolid

    PRINCIPAL INVESTIGATOR

  • Eduardo Tamayo Gómez, MD, PhD

    University Clinical Hospital of Valladolid

    STUDY CHAIR

  • José Alberto San Román Calvar, MD, PhD

    University Clinical Hospital of Valladolid

    STUDY CHAIR

  • José Ignacio Gómez Herreras, MD, PhD

    University Clinical Hospital of Valladolid

    STUDY CHAIR

Central Study Contacts

Héctor Cubero, MD

CONTACT

+34649381490hektorkubero@hotmail.com

Héctor Cubero, MD

CONTACT

+34649381490hektokubero@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 7, 2015

Study Start

January 1, 2014

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

ES(1)