Quantitative Assessment and Characterization of Microvascular Function Using Diffuse Optical Tomography

NCT03411213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-05-17

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

diffuse optical tomography

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.

Sponsors & Collaborators

  • University of Sheffield

    collaborator OTHER
  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Timothy Chico · University of Sheffield

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-11
Primary Completion
2020-03-26
Completion
2020-03-26

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03411213 on ClinicalTrials.gov