The primary objective of the study is to test whether peripheral endothelial function assessed using Laser speckle contrast analysis and CED measured with ICFT are correlated.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study end point is the difference in peripheral endothelial function
between INOCA and HFpEF patients with and without CED measured with ICFT.
Secondary outcome
1) The relationship between microvascular reactivity measured using EndoPAT and
LASCA in patients with INOCA and HFpEF.
2) The difference in peripheral endothelial function measured with LASCA
between INOCA and HFpEF patients with and without an abnormal CFR and HMR
measured with ICFT
Background summary
Coronary endothelial dysfunction (CED) has been proposed to cause signs and
symptoms of myocardial ischaemia in patients with angina but no obstructive
coronary artery disease (CAD) and heart failure with preserved ejection
fraction (HFpEF) and is associated with an increased risk of adverse cardiac
events. Currently, CED can only be detected with invasive coronary function
testing (ICFT).
However, it has been suggested that CED is a component of systemic endothelial
dysfunction and is associated with endothelial dysfunction in other
microvascular beds. The cutaneous microcirculation is suitable for
microvascular function studies and has been shown to correlate with muscle
microvascular function. The recently developed Laser speckle contrast analysis
(LASCA) technique enables non-invasive monitoring of microvascular blood flow
in superficial microvascular beds. In combination with iontophoresis of
acetylcholine, nitroprusside and insulin, LASCA allows evaluation of peripheral
microvascular endothelial and smooth muscle function. While LASCA is an
established technique, the association between CED diagnosed with ICFT and an
abnormal peripheral endothelial function measured by LASCA is currently
unknown.
Study objective
The primary objective of the study is to test whether peripheral endothelial
function assessed using Laser speckle contrast analysis and CED measured with
ICFT are correlated.
Study design
Observational cross-sectional cohort study.
Study burden and risks
Study participants do not benefit from participation in this study. The burden
of this study is low. This study protocol consists of 1 additional clinical
visit which will take about 2 hours. The total risks associated with
participation are classified as being low, because the risks for adverse events
and serious adverse events from a local and transient stimulus in skin are
minimal. Iontophoresis of acetylcholine, nitroprusside and insulin does not
cause any skin damage and the used dosages are very small and as such, the
stimuli do not cause any systemic effects.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Clinical indication for elective ICFT
- Persistent angina defined as symptoms of angina at least 2 times a month for
the last 3 months
- Absence of obstructive CAD diagnosed by CCTA and/or CAG.
- Being able to speak and understand the Dutch or English language
- Signed informed consent
Exclusion criteria
- Under 18 years of age.
Design
Recruitment
Medical products/devices used
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 | NL79036.029.21 |