Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06069401 |
| Other study ID # |
NL84769.018.23 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
July 1, 2025 |
Study information
| Verified date |
October 2023 |
| Source |
Amsterdam UMC, location VUmc |
| Contact |
Roel Hoek, MD |
| Phone |
+3120-4440381 |
| Email |
roel.hoek[@]amsterdamumc.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this clinical trial is to compare non-invasive myocardial perfusion reserve (MRR)
to invasively measured MRR in patients suspected for coronary artery disease (CAD).
The main question it aims to answer is:
• what is the correlation and agreement between non-invasive and invasive MRR.
Participants suspected for CAD and referred for invasive coronary angiogram (ICA) will
receive a [15O]H2O-PET and coronary CT angiography preceding ICA. During ICA, microvascular
resistance measurements will be performed using thermodilution.
Description:
Rationale:
In at least 25% - 50% of patients with chest pain, myocardial ischemia can be present without
angiographic evidence of significant epicardial disease. In such patients, it is often
assumed that the microvasculature of the myocardium is abnormal, called coronary
microvascular dysfunction (CMD). This microvascular dysfunction constitutes a diagnostic and
therapeutic problem with considerable morbidity and associated functional limitations,
reduces quality of life, impairs outcome, and increases economic burden for healthcare
systems. In the last years, a new invasive methodology has been developed for true
quantitative investigation of the coronary microcirculation by calculation of the
microvascular resistance reserve (MRR). Non-invasively, calculating the MRR is also possible
by measuring resting and hyperemic myocardial blood flow (MBF), for example using
quantitative Positron Emission Tomography (PET). However, non-invasive MRR can only be
calculated by PET alone in the complete absence of any epicardial disease (i.e. a Fractional
Flow Reserve [FFR] of 1.0). In order to obtain information on epicardial disease without
using invasive interrogation of the coronary arteries, a method has been developed by
HeartFlow Inc. to combine PET and FFR calculated from Coronary Computed Tomography
Angiography (FFRCT). Using this method, MRR can be calculated non-invasively regardless of
the presence of epicardial disease. However, non-invasive MRR has never been validated
against invasively measured MRR.
Objective:
The main objective is to compare non-invasive MRR, obtained using PET and FFRCT
(CT-scanning), with invasively measured MRR measurement using continuous thermodilution.
Study design:
This study is a prospective validation study in which all patients will undergo dual energy
CCTA and [15O]H2O PET scan before invasive coronary angiography (ICA) in conjunction with
invasive flow/pressure and thermodilution measurements.
Study population:
Chronic coronary syndrome patients without documented coronary artery disease (CAD) referred
for ICA will be evaluated for inclusion.
Main study parameters/endpoints:
The primary endpoint will be the correlation and agreement between non-invasive and invasive
MRR. To achieve our study objective, MRR calculated by PET and FFRCT will be compared to
invasively measured MMR.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness:
A three day protocol will be completed after referral ensuring the diagnostic work-up of
patients is not delayed. On day 1 patients will undergo CCTA. On day 2, patients will receive
PET scan. Then, on day 3, irrespective of CCTA and PET results, patients will undergo ICA
with invasive pressure/thermodilution measurements. The risks of CT and PET are considered to
be low. Patients are referred for a clinically indicated ICA and as such risks of the ICA are
not deemed study-related. The risk of invasive measurements during ICA are considered low. No
direct benefit is present for the participating patients. Nevertheless, measurement of FFR,
microvascular resistance and MRR is often useful to make a better decision on performing or
deferring PCI, is helpful to better understand the nature of angina complaints in these
patients, and contributes to fine-tuning of medical treatment.
