Mayo Clinic
Rochester, Minnesota, 55905, United States
NCT Number: NCT04755140
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.
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Notify Me18 year–100 year
All sexes
Observational
Rochester, Minnesota, 55905, United States
At your first visit you will be asked to do the following:
6: Echocardiogram: You will be asked to have three echocardiograms. One to determine baseline, and then repeated at one year and two years.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.
Cognition and memory interviews will take place with the patient.
Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.
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.
Time frame: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in LV ejection fraction as a percent.
Time frame: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in LV Mass in grams.
Time frame: Echo's will be taken at baseline, 1 year, and 2 years
The echocardiogram will measure changes in concentric or eccentric hypertrophy in centimeters.
Time frame: Cobalt level will be measured at baseline, 1 year, and 2 years
The change in cobalt blood ion levels will be measured in ng/mL.
Time frame: Chromium level will be measured at baseline, 1 year, and 2 years
The change in chromium blood ion levels will be measured in ng/mL.
Time frame: Titanium level will be measured at baseline, 1 year, and 2 years
The change in titanium blood ion levels will be measured in ng/mL.
Time frame: Testing will occur at baseline, 1 year, and 2 years.
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.
Time frame: Testing will occur at baseline, 1 year, and 2 years.
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.
Mayo Clinic
Other
Evaluation and Clinical Impact of Serum and Blood Metal Ion Levels in Patients With an Endoprosthesis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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