CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
diffuse optical tomographydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03411213
NCT03411213N/ACompleted

Quantitative Assessment and Characterization of Microvascular Function Using Diffuse Optical Tomography Version

Sheffield Teaching Hospitals NHS Foundation Trust·interventional·Posted Jan 26, 2018·Updated May 17, 2022

In Brief

A clinical study evaluating diffuse optical tomography for Atherosclerosis and 2 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed Summary

Atherosclerosis is accompanied by microvascular dysfunction (an impairment of blood vessels to dilate or constrict in response to demand). The ability to reliably measure microvascular dysfunction would help identify patients at risk of myocardial infarction and test new treatments. All existing measures of microvascular dysfunction suffer significant limitations. Near Infrared Spectroscopy (NIRS) is an imaging method that uses an infrared light-source and detector (called optodes) to painlessly shines light into tissue and collect reflected light at different wavelengths. This data allows quantification of the amount of haemoglobin (blood) in the tissue and whether it is oxygenated or de-oxygenated. Diffuse optical tomography (DOT) is a powerful analysis technique for data collected from multiple NIRH optodes. Unlike most NIRS studies that use a single pair of optodes and collects a single datapoint for each wavelength over time, DOT allows three-dimensional spatial reconstruction of haemodynamic and anatomic changes in a large region of tissue over time. In preliminary work DOT had the potential to measure forearm reactive hyperaemia, a key indicator of microvascular function. Team will test whether DOT can detect differences between patients and healthy volunteers. In this work, 30 patients will be recruited with type 2 diabetes, 30 patients who have had a previous myocardial infarction and 30 healthy volunteers. The Investigator will also recruit 50 patients who are on waiting lists for coronary angiography. The DOT will be used to measure participants' microvascular function after brachial artery occlusion by a blood pressure cuff. The Investigator will then examine whether DOT can detect differences between healthy volunteers, diabetics, and patients with a previous heart attack, and whether DOT is able to predict existence of coronary artery disease on angiography. If successful, DOT can be developed for assessment of microvascular function to the point where it could be applied to clinical studies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 26, 2018
Enrollment StartJan 11, 2016
Primary CompletionMar 26, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 8.4 years ago

Interventions

diffuse optical tomographydevice

Optical tomography is a form of computed tomography that creates a digital volumetric model of an object by reconstructing images made from light transmitted and scattered through an object.