Does OCT Imaging Allow us to See Blood Vessel Development in and Around Deposits of Fat and Calcium Inside Blood Vessels

NCT03182348 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2021-05-03

No results posted yet for this study

Summary

Cardiovascular disease is the leading cause of illness and death in the world. The disease involves narrowing of blood vessels due to deposits of fat which can become coated in calcium. It is treated by percutaneous coronary intervention in which a balloon is passed down the blood vessel to remove the obstruction and where appropriate a stent is placed in the blood vessel to scaffold it.

Early stage research suggests that the growth of small blood vessels in and around the deposits of fat and calcium leads to the growth of the deposit and may contribute to plaque rupture into the vessel leading to clot formation the process which leads to heart attacks. Drugs which prevent the development of these small blood vessel restrict the development of the deposit, and those that encourage the development of these small blood vessel also increase the development of the deposit. Researchers would like to find out more about the system of blood vessels around deposits of fat and calcium in the larger blood vessels. This involves looking just beneath the surface of the blood vessel wall, and requires a detailed and accurate image. Researchers on this project would like to find out if optical coherence tomography (OCT) is a suitable technique for imaging in this way.

OCT works like an ultrasound, but using light instead of sound waves. The additional imaging will prolong the clinical procedure by 10-15 minutes.

Conditions

Interventions

PROCEDURE

Optical coherence tomography

As part of the clinical angioplasty procedure the patient will have a coronary guidewire passed down the artery usually from the groin to the heart which is used to position balloons and stents. OCT passes over the wire in the same way. From the patients perspective the procedure may take a small amount of additional time - maximum 10-15 minutes. We would like to be able to pass a second wire down the same coronary artery called a 'buddy wire' which is sometimes required in coronary procedures. This would be used to inflate a balloon at low pressure near the area of interest in the heart in order either to exclude blood or to oppose the OCT catheter to the vessel wall if required.

Sponsors & Collaborators

  • University of Leicester

    lead OTHER

Principal Investigators

  • David Adlam, BA,BM,BCH,DPhil,MRCP · NIHR Leicester Cardiovascular BRU

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2020-03-31
Completion
2020-03-31

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 NCT03182348 on ClinicalTrials.gov