Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02894671
Acronym
IMAandGENDER
Enrollment
100
Registered
2016-09-09
Start date
2015-02-28
Completion date
2016-02-29
Last updated
2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Group Identification

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.

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).

Interventions

OTHERblood exams

in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
IMA dosageone yearDosage of IMA (mg/ml), with ELISA assay for each patient

Secondary

MeasureTime frameDescription
iron, transferrin dosagesone yearDosage of iron and transferrin (mg/ml) values in patients blood
Ferritin dosagesone yearDosage of ferritin (ng/ml) values in patients blood

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026