NCT04755140

Endoprosthesis Metal Toxicity Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Questionnaires	The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.
BEHAVIORAL	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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2021-03-19
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2021-02-15
• Last updated: 2024-12-16

Locations

1 site across 1 country: United States