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

NCT03182348 | Completed

• 1 other identifier: 0255
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Cardiovascular Disease

Keywords

Microvessels; Cardiovascular disease; OCT

Outcome Measures

Primary Outcomes (1)

• Markers of high risk coronary diseases

  Novel OCT features as potential markers of high risk coronary diseases

  through study completion, an average of 1 year (Aprox March 2018)

Study Arms (1)

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.

Procedure: Optical coherence tomography

Interventions

Optical coherence tomography PROCEDURE

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.

Also known as: OCT

Optical coherence tomography

Eligibility Criteria

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

Study Population

Patients scheduled for elective percutaneous coronary intervention or coronary angiography with a view to coronary intervention on routine clinical criteria with diagnosis of angina pectoris, unstable angina or acute coronary syndrome with angiographically significant stenosis(es) (\>70%) of one or more native coronary arteries.

You may qualify if:

• Patients scheduled for elective percutaneous coronary intervention or coronary angiography with a view to coronary intervention on routine clinical criteria with diagnosis of angina pectoris, unstable angina or acute coronary syndrome with angiographically significant stenosis(es) (\>70%) of one or more native coronary arteries.

You may not qualify if:

• Primary angioplasty for S T -elevation myocardial infarction. Clinically unstable patients.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

NIHR Cardiovascular BRU

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• David Adlam, BA,BM,BCH,DPhil,MRCP

  NIHR Leicester Cardiovascular BRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: June 9, 2017
• Study Start: September 1, 2012
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 3, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)