Group Identification Clinical Trial
— IMAandGENDEROfficial title:
Ischemia Modified Albumin (IMA) Expression in the Male and Female Population
Verified date | September 2016 |
Source | Istituto Ortopedico Rizzoli |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
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.
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) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica | Bologna |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli |
Italy,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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N/A |