Heart and Blood Diseases

All Conditions

Behaviors and Mental Disorders

Neoplasms

Musculoskeletal Diseases

Heart Diseases

Cognitive Dysfunction

Bone Neoplasms

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Bone Diseases

The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.

Questionnaires

Cognition and memory interviews will take place with the patient.

Interviews

Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.

Blood Test

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.

Echocardiogram

Matthew Houdek, MD

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.

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.

Blood will be collected from patients and ran through a CyTOF procedure to identify immune cells within the samples.

Endoprosthesis Metal Toxicity Study

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

The echocardiogram will measure changes in LV ejection fraction as a percent.

The echocardiogram will measure changes in LV Mass in grams.

The echocardiogram will measure changes in concentric or eccentric hypertrophy in centimeters.

The change in cobalt blood ion levels will be measured in ng/mL.

The change in chromium blood ion levels will be measured in ng/mL.

The change in titanium blood ion levels will be measured in ng/mL.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoprosthesis Metal Toxicity Study	NCT04755140	Bone Tumor Cancer of Bone Heart Diseases Cognitive Impai... Cognitive Decli... Chemotherapy Ef... Memory Problem	Questionnaires Interviews Blood Test Echocardiogram	18 Years - 100 Years	Mayo Clinic
Endoprosthesis Metal Toxicity Study	NCT04755140	Bone Tumor Cancer of Bone Heart Diseases Cognitive Impai... Cognitive Decli... Chemotherapy Ef... Memory Problem	Questionnaires Interviews Blood Test Echocardiogram	18 Years - 100 Years	Mayo Clinic
Endoprosthesis Metal Toxicity Study	NCT04755140	Bone Tumor Cancer of Bone Heart Diseases Cognitive Impai... Cognitive Decli... Chemotherapy Ef... Memory Problem	Questionnaires Interviews Blood Test Echocardiogram	18 Years - 100 Years	Mayo Clinic

Spots Global Cancer Trial Database for endoprosthesis