Ignite Creation Date:
2024-05-06 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05103943
Status:
RECRUITING
Last Update Posted:
2023-07-20
First Post:
2021-09-30
Brief Title:
Amyloidosis TTR Flow Reserve Evaluation
Sponsor:
Centre Hospitalier Régional dOrléans
Organization:
Centre Hospitalier Régional dOrléans
Study Overview
Official Title:
Amyloidosis TTR Flow Reserve Evaluation
Status:
RECRUITING
Status Verified Date:
2024-08
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:
AMYTRE
Brief Summary:
Anginal symptoms and signs of ischemia have been reported in some patients with cardiac amyloidosis TTR without obstructive epicardial coronary artery disease CAD
It was found that coronary microvascular dysfunction was highly prevalent in subjects with cardiac amyloidosis even in the absence of epicardial CAD The investigators found lower stress and rest myocardial blood flow MBF and lower myocardial flow reserve MFR in their cardiac PET Positron emission tomography study 13N including 21 patients
The advances in SPECT technology including cadmium zinc telluride CZT detectors allow to evaluate the MBF and MFR estimation by SPECT as shown in both experimental animal models and also in clinical studies with comparison to PET
SPECT is more widely available than cardiac PET Thus the investigators would like
1 to confirm the results of Dorbala et al using SPECT and
2 to go further with evaluation of the effect of Tafamidis on microvascular dysfunction
It was found that coronary microvascular dysfunction was highly prevalent in subjects with cardiac amyloidosis even in the absence of epicardial CAD The investigators found lower stress and rest myocardial blood flow MBF and lower myocardial flow reserve MFR in their cardiac PET Positron emission tomography study 13N including 21 patients
The advances in SPECT technology including cadmium zinc telluride CZT detectors allow to evaluate the MBF and MFR estimation by SPECT as shown in both experimental animal models and also in clinical studies with comparison to PET
SPECT is more widely available than cardiac PET Thus the investigators would like
1 to confirm the results of Dorbala et al using SPECT and
2 to go further with evaluation of the effect of Tafamidis on microvascular dysfunction
Detailed Description:
None
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