Troponin T Elevation in Patient Undergoing Hip Fracture Surgery

NCT01352754 | Unknown

• 1 other identifier: 0394-HMO-CTIL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fracture

Keywords

Hip fracture; Troponin T; myocardial infarction

Outcome Measures

Primary Outcomes (2)

• The number of patients with elevated HS Tn T levels post operatively.

  One year

• Cardiac mortality

  one year

Secondary Outcomes (2)

• Total mortality

  One year

• Any hospitlization

  One year

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted with traumatic femoral neck fracture

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah hebrew university medical centers

Jerusalem, Israel

Location

MeSH Terms

Conditions

Hip Fractures; Myocardial Infarction

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• David Rott, MD

  Hadassah-Hebrew University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 12, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

IL (1)