Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06069401
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-09-20
Brief Title:
The MASTER-PACT Study
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Microvascular Resistance Reserve Assessment Derived From Absolute Flow and Resistance by PET and CT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
MASTER-PACT
Brief 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 15OH2O-PET and coronary CT angiography preceding ICA During ICA microvascular resistance measurements will be performed using thermodilution
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 15OH2O-PET and coronary CT angiography preceding ICA During ICA microvascular resistance measurements will be performed using thermodilution
Detailed 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 ie a Fractional Flow Reserve FFR of 10 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 15OH2O PET scan before invasive coronary angiography ICA in conjunction with invasive flowpressure 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 parametersendpoints
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 pressurethermodilution 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
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 ie a Fractional Flow Reserve FFR of 10 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 15OH2O PET scan before invasive coronary angiography ICA in conjunction with invasive flowpressure 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 parametersendpoints
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 pressurethermodilution 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
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