Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755140
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2021-01-28
Brief Title:
Endoprosthesis Metal Toxicity Study
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Evaluation and Clinical Impact of Serum and Blood Metal Ion Levels in Patients With an Endoprosthesis
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 42-5 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
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 42-5 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL147155-02 | NIH | None | httpsreporternihgovquickSearchR01HL147155-02 |
| R01AG060920 | NIH | None | None |