Ischemia Modified Albumin (IMA) Expression in the Male and Female Population

Group Identification Clinical Trial

— IMAandGENDER  

Official title:

Ischemia Modified Albumin (IMA) Expression in the Male and Female Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894671
• Other study ID #: 83/14
• Status: Completed
• Phase: N/A
• First received: February 12, 2016
• Last updated: September 5, 2016
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: September 2016
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The study has as general objective to analyze in the adult population, (male and female) the presence of a very common protein, in its normal form and modified, isolated from the blood of patients and called albumin. The opportunity to observe the distribution of this protein in the population, provides the basis to be able to perform this type of assay also in the population of patients with pathologies, in the near future, with the aim of increasing knowledge on the subjective tolerability to orthopedic implants.

Description:

100 patients, waiting for elective surgical intervention (such as hip replacement or primary knee ligament reconstruction, arthroscopy), distributed evenly by gender and age (50 men, 50 women including 25 postmenopausal and 25 in bearing age) and afferent to the Department of Surgery Prosthetic hip and knee of our Institute, will be enrolled. At execution time of blood sampling routine, a further specimen of whole blood (7 ml) will be added which will be sent to the Medical technology laboratory for IMA dosage. In addition, total albumin, ferritin, transferrin and serum iron will be analyzed from clinical pathological laboratory. The investigators will be able to analyze the IMA and normalized IMA distributions with respect to gender factor and correlation with the three listed blood tests (ferritin, transferrin and serum iron).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

• Inclusion Criteria:

• caucasic

• signed informative consensus

• Exclusion Criteria:

• patients wearing articular devices

• pregnant (for female)

• fractured patients

• patients with oncologic diseases, hemochromatosis, hepatic diseases, thalassaemia, diabetes, anemia (Hb<9)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Group Identification
• Ischemia

Intervention

Other:
• blood exams
in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Bar-Or D, Rael LT, Lau EP, Rao NK, Thomas GW, Winkler JV, Yukl RL, Kingston RG, Curtis CG. An analog of the human albumin N-terminus (Asp-Ala-His-Lys) prevents formation of copper-induced reactive oxygen species. Biochem Biophys Res Commun. 2001 Jun 15;284(3):856-62. — View Citation

Catalani S, Leone R, Rizzetti MC, Padovani A, Apostoli P. The role of albumin in human toxicology of cobalt: contribution from a clinical case. ISRN Hematol. 2011;2011:690620. doi: 10.5402/2011/690620. Epub 2010 Oct 31. — View Citation

Govender R, De Greef J, Delport R, Becker PJ, Vermaak WJ. Biological variation of ischaemia-modified albumin in healthy subjects. Cardiovasc J Afr. 2008 May-Jun;19(3):141-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IMA dosage	Dosage of IMA (mg/ml), with ELISA assay for each patient	one year	Yes
Secondary	iron, transferrin dosages	Dosage of iron and transferrin (mg/ml) values in patients blood	one year	Yes
Secondary	Ferritin dosages	Dosage of ferritin (ng/ml) values in patients blood	one year	Yes