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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG060920 | U.S. NIH Grant/Contract | View source | |
| R01HL147155-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institute on Aging (NIA) | NIH |
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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:
6: Echocardiogram: You will be asked to have three echocardiograms. One to determine baseline, and then repeated at one year and two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoprosthesis | Patients with a endoprosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Behavioral | The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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150 patients to complete cardiology part of the study (questionnaires, blood test, echocardiogram).
150 patients to complete cognitive part of the study (questionnaires, interviews, blood test).
Patient groups may overlap.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Houdek, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 8, 2023 | Dec 12, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D006331 | Heart Diseases |
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D007407 | Interviews as Topic |
| D006403 | Hematologic Tests |
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Blood will be collected from patients and ran through a CyTOF procedure to identify immune cells within the samples.
| Interviews | Behavioral | Cognition and memory interviews will take place with the patient. |
|
| Blood Test | Diagnostic Test | Three blood draws will occur to assess patients immune response, metal levels, and cardiac health. |
|
| Echocardiogram | Diagnostic 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. |
|
| 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. |
| D002318 |
| Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |