Endoprosthesis Metal Toxicity Study

Heart Diseases Clinical Trial

Official title:

Evaluation and Clinical Impact of Serum and Blood Metal Ion Levels in Patients With an Endoprosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04755140
• Other study ID #: 20-008408
• Secondary ID: R01AG060920R01HL
• Status: Completed
• Start date: March 19, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to investigate whether patients who previously had endoprosthesis surgery experience memory, thinking, or heart problems. It will also help determine how often these problems occur.

Description:

At your first visit you will be asked to do the following:

1. Sign the consent document.

2. Patient Interview: An interview will be conducted by the study coordinator on the research team. They will ask your past surgical history, health history, medications, and your cognition.

3. Informant Interview: A close friend, spouse of relative of you will be interviewed about your day-day cognition.

4. Memory Interview: You will be evaluated on your memory and thinking skills three total times. One to determine baseline, and then repeated at one year and two years. You will answer questions that evaluate various thinking abilities such as concentration, memory, reasoning, and learning.

5. Blood Draw: You will have a blood draw three times (4.2-5 tablespoons) to determine your baseline, 1 year, and 2 year research results.

6: Echocardiogram: You will be asked to have three echocardiograms. One to determine baseline, and then repeated at one year and two years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patient has an endoprosthesis after extremity malignancy

Exclusion Criteria:

• Current fracture or infection around the endoprosthesis

• Patient is pregnant

Related Conditions & MeSH terms

• Bone Neoplasms
• Bone Tumor
• Cancer of Bone
• Chemotherapy Effect
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Heart Diseases
• Memory Problem

Intervention

Behavioral:
• Questionnaires
The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.
• Interviews
Cognition and memory interviews will take place with the patient.

Diagnostic Test:
• Blood Test
Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.
• Echocardiogram
Each echocardiogram takes about 3 hours and 30 minutes. This test uses sound waves to look at your heart. The person doing the test will press on your chest with a machine to obtain the pictures. The pressure may be uncomfortable. The echocardiogram will involve an image enhancement agent infusion to obtain better images.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echo - Left Ventricular Ejection Fraction	The echocardiogram will measure changes in LV ejection fraction as a percent.	Echo's will be taken at baseline, 1 year, and 2 years
Primary	Echo - Left Ventricular Mass	The echocardiogram will measure changes in LV Mass in grams.	Echo's will be taken at baseline, 1 year, and 2 years
Primary	Echo - Heart Hypertrophy	The echocardiogram will measure changes in concentric or eccentric hypertrophy in centimeters.	Echo's will be taken at baseline, 1 year, and 2 years
Primary	Cobalt Metal Levels	The change in cobalt blood ion levels will be measured in ng/mL.	Cobalt level will be measured at baseline, 1 year, and 2 years
Primary	Chromium Metal Levels	The change in chromium blood ion levels will be measured in ng/mL.	Chromium level will be measured at baseline, 1 year, and 2 years
Primary	Titanium Metal Levels	The change in titanium blood ion levels will be measured in ng/mL.	Titanium level will be measured at baseline, 1 year, and 2 years
Secondary	Psychometrist Testing - Intelligence Score	The change in participants' intelligence will be measured using the Wechsler Adult Intelligence Scale. The scale is based of scores of 50 to 150. The higher the score the better the outcome. The average outcome will be a score of 100.	Testing will occur at baseline, 1 year, and 2 years.
Secondary	Psychometrist Testing - Memory Score	The change in participants' memory will be measured using the Wechsler Adult Memory Scale. The scale is based of scores of 50 to 150. The higher the score the better the outcome. The average outcome will be a score of 100.	Testing will occur at baseline, 1 year, and 2 years.