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

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ClinicalTrials.gov Identifier: NCT02894671
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Giovanni Bracci, Istituto Ortopedico Rizzoli

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
Group Identification Other: blood exams

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).

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ischemia Modified Albumin (IMA) Expression in the Male and Female Population
Study Start Date : February 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Group/Cohort 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




Primary Outcome Measures :
  1. IMA dosage [ Time Frame: one year ]
    Dosage of IMA (mg/ml), with ELISA assay for each patient


Secondary Outcome Measures :
  1. iron, transferrin dosages [ Time Frame: one year ]
    Dosage of iron and transferrin (mg/ml) values in patients blood

  2. Ferritin dosages [ Time Frame: one year ]
    Dosage of ferritin (ng/ml) values in patients blood


Biospecimen Retention:   Samples Without DNA
Serum vials


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
25 males under 45y, 25 males over 45y, 25 fertile females and 25 infertile females
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894671


Locations
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Italy
Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Principal Investigator: Giovanni Bracci, MD Istituto Ortopedico Rizzoli