Peripheral Microvascular Blood Flow in ANOCA

NCT05610410 | Completed

• 1 other identifier: VUmc_2021.0615
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

An observational cross-sectional cohort study investigating whether peripheral endothelial function assessed using Laser speckle contrast analysis and coronary endothelial function measured with invasive coronary function testing are correlated in patients with angina and no obstructive coronary arteries.

Conditions

ANOCA - Angina With Non-obstructive Coronary Arteries; HFpEF - Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Laser speckle contrast analysis (LASCA)

  Peripheral microvascular function measured with Laser speckle contrast analysis (LASCA) between patients with non-obstructive coronary artery disease with and without Coronary endothelial dysfunction. LASCA measures microvasclar function non invasively by measure perfusion units (APU/mmHg.)

  35 minutes

Secondary Outcomes (1)

• EndoPAT

  15 minutes

Study Arms (2)

Patients with angina and no obstructive coronary arteries

Other: Laser speckle contrast analysis

Patients with HFpEF

Other: Laser speckle contrast analysis

Interventions

Laser speckle contrast analysis OTHER

Peripheral endothelial function assessment using Laser speckle contrast analysis and Peripheral reactive hyperemia assessment using EndoPAT

Also known as: EndoPAT

Patients with HFpEF; Patients with angina and no obstructive coronary arteries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is designed to evaluate INOCA patients with a clinical indication of ICFT because of persistent angina without obstructive coronary artery disease and HFpEF patients with a clinical indication of ICFT.

You may qualify if:

• Clinical indication for elective invasive coronary function test (ICFT)
• 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
• 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)

You may not qualify if:

• Under 18 years of age
• Unable or unwilling to undergo ICFT

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Maastricht University Medical Center: collaborator

Study Sites (1)

Amsterdam UMC, lcoation VUmc

Amsterdam, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FESC

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 9, 2022
• Study Start: January 1, 2022
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: December 3, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)