NCT05103943

Amyloidosis TTR Flow Reserve Evaluation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Amyloid Cardiomyopathy

Interventions

Type	Name	Description
OTHER	SPECT MPI	SPECT MPI including dynamic acquisitions for stress, rest MBF and MFR

Timeline

• Start date: 2022-02-24
• Primary completion: 2026-12-11
• Completion: 2026-12-11
• First posted: 2021-11-02
• Last updated: 2025-12-23

Locations

4 sites across 1 country: France