The primary objective of this study is to compare MRR measured at two locations in the LAD (proximal LAD and mid-LAD, i.e. distal to the first large diagonal branch) and to investigate if MRR remains unchanged with this change of myocardial mass.
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to compare MRR measured at two locations
in the LAD (proximal LAD and mid-LAD, i.e. distal to the first large diagonal
branch) and to investigate if MRR remains unchanged with this change of
myocardial mass.
Secondary outcome
na
Background summary
Coronary microvascular dysfunction (CMD) is increasingly recognized as a common
cause of chest pain and is associated with impaired quality of life and poor
clinical outcome. This diagnosis can be considered when patients have chest
pain with normal coronary arteries (ANOCA; angina non obstructive coronary
arteries).
Until recently, precise techniques to evaluate and quantify CMD were not
available.
For decades, only substitutes of flow and resistance were used such as
Doppler-CFR and bolus thermodilution-based IMR, which are either crude,
non-specific, difficult to obtain in a considerable number of patients, and
operator-dependent.
Since 2016, direct flow and resistance measurement in the coronary circulation
has become feasible for clinical use in the catheterization laboratory, using
continuous intracoronary thermodilution with low infusion rates of saline.
This method directly quantifies absolute coronary blood flow (Q) and
microvascular resistance (Rµ) at rest and at hyperemia, providing an accurate,
reproducible and quantitative evaluation of the coronary microcirculation. This
is now part of the standard care in the catheterization lab when investigating
the microcirculation in patients with ANOCA.
From the Continuous thermodilution measurements enable also calculation of
Microvascular Resistance Reserve (MRR) can be directly performed. The index
MRR, introduced in 2021, is simply calculated from the flow and pressure
measurements and is a specific measure of the coronary microcirculation,
independent of any kind of hidden or overt epicardial disease. In addition, MRR
has the theoretical advantage of being independent of the myocardial mass
(perfusion territory) supplied by the respective coronary artery. However,
direct proof of this latter characteristic in humans, has not been obtained so
far.
The aim of this present exploratory study, is to obtain such direct proof by
measuring MRR not only in the proximal LAD artery, but also in the mid-LAD,
just distal to a large diagonal branch and showing that both values are
(almost) equal.
Study objective
The primary objective of this study is to compare MRR measured at two locations
in the LAD (proximal LAD and mid-LAD, i.e. distal to the first large diagonal
branch) and to investigate if MRR remains unchanged with this change of
myocardial mass.
Study design
A prospective, exploratory study comparing MRR in 30 patients at two locations
in the LAD artery:
Proximal LAD ( regular measurement) and mid-LAD (study measurement).
Study burden and risks
none
hoefkestraat 64
eindhoven 5611RN
NL
hoefkestraat 64
eindhoven 5611RN
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study a subject must meet all of
the following criteria:
• Patient must be accepted/planned for regular coronary function testing based
on the decision of the cardiologist. Usually, these will be patients with
typical angina but (almost) normal coronary arteries
• Age >= 18 years
Exclusion criteria
• Extremely tortuous LAD vessel
• Proximal LAD diameter less than 2.5 mm
• Pregnancy
• Unable to provide consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87694.100.24 |