IMAandGENDER: Ischemia Modified Albumin (IMA) Expression in the Male and Female Population
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| male under 45y blood exams performed on males under 45years (in a range of 20-90 years) not wearing articular devices, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) |
Other: blood exams
in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin
|
| male over 45y blood exams performed on males over 45years (in a range of 20-90 years) not wearing articular devices, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) |
Other: blood exams
in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin
|
| fertile female blood exams performed on fertile females (in a range of 20-90 years) not wearing articular devices, no pregnant, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) |
Other: blood exams
in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin
|
| infertile female blood exams performed on infertile females (in a range of 20-90 years) not wearing articular devices, no pregnant, without fractures, and without these diseases: oncologic, hemochromatosis, hepatic, thalassaemia, diabetes, anemia (Hb<9) |
Other: blood exams
in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin
|
Outcome Measures
Primary Outcome Measures
- IMA dosage [one year]
Dosage of IMA (mg/ml), with ELISA assay for each patient
Secondary Outcome Measures
- iron, transferrin dosages [one year]
Dosage of iron and transferrin (mg/ml) values in patients blood
- Ferritin dosages [one year]
Dosage of ferritin (ng/ml) values in patients blood
Eligibility Criteria
Criteria
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica | Bologna | Italy | 40136 |
Sponsors and Collaborators
- Istituto Ortopedico Rizzoli
Investigators
- Principal Investigator: Giovanni Bracci, MD, Istituto Ortopedico Rizzoli
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
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