Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
43 participants
OBSERVATIONAL
2022-01-01
2024-09-05
Brief Summary
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Detailed Description
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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.
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 population: 51 patients over the age of 18 with signs and symptoms of ischemia with no obstructive coronary arteries (INOCA) and a clinical indication for ICFT because of persistent angina without obstructive coronary artery disease and 58 patients with heart failure with preserved ejection fraction (HFpEF) and a clinical indication for ICFT.
Primary study endpoint: The main study end point is the difference in peripheral endothelial function between patients with and without CED measured with ICFT in the INOCA group and the HFpEF group.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study participants do not benefit from participation in this study. The burden of this study is low. The aim is that study procedures will be performed within 24 hours of the elective ICFT and study participants do not have to come to the hospital for an additional visit. 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with angina and no obstructive coronary arteries
Laser speckle contrast analysis
Peripheral endothelial function assessment using Laser speckle contrast analysis and Peripheral reactive hyperemia assessment using EndoPAT
Patients with HFpEF
Laser speckle contrast analysis
Peripheral endothelial function assessment using Laser speckle contrast analysis and Peripheral reactive hyperemia assessment using EndoPAT
Interventions
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Laser speckle contrast analysis
Peripheral endothelial function assessment using Laser speckle contrast analysis and Peripheral reactive hyperemia assessment using EndoPAT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Suited for one of the study groups:
* Persistent angina, defined as symptoms of angina; or
* HFpEF, diagnosed according to the European Society of Cardiology 2021 heart failure guidelines
* Absence of obstructive CAD, documented before inclusion, defined as
* Coronary Computed Tomography Angiography (CCTA) - indicative of absence of obstructed coronary arteries, or
* Coronary angiography (CAG) - \<50% diameter stenosis (DS) in the epicardial coronary arteries or (fractional flow reserve (FFR) \>0.80 or instant wave free ratio (iFR) \>0.89)
Exclusion Criteria
* Unable or unwilling to undergo ICFT
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Amsterdam UMC, location VUmc
OTHER
Responsible Party
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Yolande Appelman
MD, PhD, FESC
Locations
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Amsterdam UMC, lcoation VUmc
Amsterdam, , Netherlands
Countries
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Other Identifiers
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VUmc_2021.0615
Identifier Type: -
Identifier Source: org_study_id