Cardiovascular DiseaseNCT03182348
Does OCT Imaging Allow us to See Blood Vessel Development in and Around Deposits of Fat and Calcium Inside Blood Vessels
An observational study of Cardiovascular Disease, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Optical coherence tomography
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Primary angioplasty for S T -elevation myocardial infarction. Clinically unstable patients.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Cardiovascular BRU
Leicester, Leicestershire, LE3 9QP
About this study
Official title: Coronary Optical Coherence Tomography Correlation and Strain Mapping to Investigate Human Atherosclerosis: a Feasibility Study
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.
Read the detailed description
Cardiovascular disease is the leading cause of illness and death in the world. Central to the process of this disease is the narrowing of blood vessels due to deposits of fatty residue which can become coated in calcium. Significant narrowing of the blood vessels is treated by percutaneous coronary intervention in which a balloon is inflated and passed down the blood vessel to remove the obstruction and where appropriate a stent is placed in the blood vessel to scaffold it.
Potential participants are those who have been scheduled for a percutaneous coronary intervention, are stable, and have a diagnosis of angina pectoris, unstable angina or acute coronary syndrome. These patients will be identified and screened by their healthcare team. Potential participants will be given study information by their healthcare team, or identified to the research team who will provide study information. The initial approach may be in clinic, in hospital, or by post.
Participants will be asked to give written informed consent to participate in the study. At the clinical pre-procedure visit consent is sought, exclusion and inclusion criteria checked.
Procedure: On the day of the patients procedure they will receive standard clinical care comprising angiography (imaging of the blood vessel), angioplasty (removal of fatty deposits with a balloon) and stenting. Before and after the procedure the patient will receive medication and after care as per standard clinical care. Those patients who are clinically indicated for stenting will undergo OCT imaging prior to the angioplasty and stenting.
The researchers need to allow flexibility in the process of acquiring the OCT images, so they can optimize the quality of the image. Therefore, the speed of pullback (removal of the catheter) and choice of blood clearing agents will not be pre-specified. Serial images of the same part of the vessel may be taken.
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.
If a patient returns for subsequent percutaneous coronary intervention they will be invited to participate again.
- Conditions
- Cardiovascular Disease
- Being tested
- Optical coherence tomography
- Keywords
- Microvessels, Cardiovascular disease, OCT
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyProcedure or surgery
Also called OCT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of high risk coronary diseases
Novel OCT features as potential markers of high risk coronary diseases
Measured: through study completion, an average of 1 year (Aprox March 2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study startSep 2012
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Adlam, BA,BM,BCH,DPhil,MRCP, Principal investigator, NIHR Leicester Cardiovascular BRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182348
- Sponsor's protocol ID
- 0255
- Status last verified
- Jul 2020
- First submitted
- 6 Feb 2013
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Optical Coherence Tomography Correlation and Strain Mapping to Investigate Human Atherosclerosis: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03182348
- Acronym / sponsor ID
- 0255
- Conditions
- Cardiovascular Disease
- Keywords
- Microvessels, Cardiovascular disease, OCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular disease is the leading cause of illness and death in the world. Central to the process of this disease is the narrowing of blood vessels due to deposits of fatty residue which can become coated in calcium. Significant narrowing of the blood vessels is treated by percutaneous coronary intervention in which a balloon is inflated and passed down the blood vessel to remove the obstruction and where appropriate a stent is placed in the blood vessel to scaffold it.
Potential participants are those who have been scheduled for a percutaneous coronary intervention, are stable, and have a diagnosis of angina pectoris, unstable angina or acute coronary syndrome. These patients will be identified and screened by their healthcare team. Potential participants will be given study information by their healthcare team, or identified to the research team who will provide study information. The initial approach may be in clinic, in hospital, or by post.
Participants will be asked to give written informed consent to participate in the study. At the clinical pre-procedure visit consent is sought, exclusion and inclusion criteria checked.
Procedure: On the day of the patients procedure they will receive standard clinical care comprising angiography (imaging of the blood vessel), angioplasty (removal of fatty deposits with a balloon) and stenting. Before and after the procedure the patient will receive medication and after care as per standard clinical care. Those patients who are clinically indicated for stenting will undergo OCT imaging prior to the angioplasty and stenting.
The researchers need to allow flexibility in the process of acquiring the OCT images, so they can optimize the quality of the image. Therefore, the speed of pullback (removal of the catheter) and choice of blood clearing agents will not be pre-specified. Serial images of the same part of the vessel may be taken.
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.
If a patient returns for subsequent percutaneous coronary intervention they will be invited to participate again.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical coherence tomography | – | Procedure: Optical coherence tomographyAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Primary angioplasty for S T -elevation myocardial infarction. Clinically unstable patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomographyAlso: OCTAs 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 or surgery | Optical coherence tomography |
Primary outcome
Markers of high risk coronary diseases
Time frame: through study completion, an average of 1 year (Aprox March 2018)
Novel OCT features as potential markers of high risk coronary diseases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Adlam, BA,BM,BCH,DPhil,MRCP principal investigator
NIHR Leicester Cardiovascular BRU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of high risk coronary diseases (time frame: through study completion, an average of 1 year (Aprox March 2018)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.