Troponin T Elevation in Patient Undergoing Hip Fracture Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David Rott, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01352754
First received: May 11, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

Background: Patients undergoing hip fracture surgery are elderly and usually have co-morbidities; hence they are at risk for perioperative MI. Troponin is the gold standard for diagnosis of myocardial damage and currently the cornerstone of MI diagnosis. Perioperative troponin elevation is a poor prognosis factor. The significance of minor troponin elevation, detected by highly sensitivity troponin T assay, is unknown.

Objectives: To determine the frequency of perioperative troponin T elevation using highly sensitivity troponin T assay, and to determine the clinical significance of this elevation.

Methods: Serum Troponin T levels of patients undergoing hip fracture surgery will be tested prior to surgery 48 hrs and 72 hrs after surgery, using highly sensitivity troponin T assay.

Patients will be followed for 1 year. Primary outcomes- The number of patients with elevated troponin levels perioperatively and cardiac mortality at 3 months, 6 months and 1 year.


Condition
Hip Fracture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognosis Significance of Troponin T Elevation as Detected by Highly Sensitive Assay in Patient Undergoing Hip Fracture Surgery

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • The number of patients with elevated HS Tn T levels post operatively. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Cardiac mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total mortality [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Any hospitlization [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Background and Rational

Hip fractures are an important cause of morbidity and mortality in the elderly. Surgery (i.e. total hip fracture surgery or replacement) is associated with better outcome; however these elderly patients have other comorbidities which put them at risk for non surgical perioperative complications .

Peri-operative myocardial infarction (MI) is associated with increased mortality and morbidity . Peri-operative MI currently diagnosed by presence of either symptoms or ischemic ECG changes, together with an elevated troponin level as measured by conventional assay.

The new highly sensitive troponin T (HS Tn T) assay, permitting measurement of concentrations that are lower by a factor of 10 than those measurable with conventional assays .

Research Objectives

The fundamental objective of our research is to further elucidate the magnitude and clinical relevance of minor perioperative TnT elevations.

Our specific objectives are:

A.To determine what is the frequency of HS Tn T elevation in patients undergoing hip fracture surgery.

B.To determine whether the presence of perioperative Tn T elevation using the HS assay is associated with higher mortality and morbidity.

Primary end points:

  1. The number of patients with elevated HS Tn T levels postoperatively.
  2. Cardiac mortality at 3 moths, 6 months and 1 year.

Secondary end points:

  1. Total mortality at 3 moths, 6 months and 1 year.
  2. Hospitalization for ACS and/or CHF at 3 months, 6 months and 1 year.

Methods

Patients admitted with traumatic femoral neck fracture will be recruited if surgery is planned.

Clinical evaluation for symptoms and signs of myocardial ischemia will be performed prior to surgery and 24 hrs after surgery.

Serum Tn T levels will be tested prior to surgery 48 hrs and 72 hrs after surgery, using HS Tn T assay.

ECG monitoring will be performed prior to surgery and 24 hrs after surgery. Patients will be followed for 1 year.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients admitted with traumatic femoral neck fracture

Criteria

Inclusion Criteria:

  • Patients older than 65 years, admitted with traumatic femoral neck fracture undergoing surgery

Exclusion Criteria:

  • Patients who will not undergo surgery
  • Patients whom clinical singes and baseline troponin (prior to surgery) will suggest an acute myocardial infarction
  • Patient younger than 65 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352754

Locations
Israel
Hadassah hebrew university medical centers
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: David Rott, MD Hadassah-Hebrew University Hospital
  More Information

No publications provided

Responsible Party: David Rott, Consultant, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01352754     History of Changes
Other Study ID Numbers: 0394-HMO-CTIL
Study First Received: May 11, 2011
Last Updated: December 11, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Hip fracture
Troponin T
myocardial infarction

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014