Stable AnginaVALID-PET-CTNCT04205110
Development and Validation of a Fast, Semi-Automated Hybrid Imaging Platform to Assess Coronary Atherosclerotic Plaque Morphology, Endothelial Shear Stress and Arterial Inflammation: A Proof of Principle Study (VALID-PET-CT)
An observational study of Stable Angina and Coronary Artery Disease, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Imaging the inside of coronary arteries (intravascular imaging) offers great insight into the assessment and treatment of coronary artery disease. Over time, substances such as fat, cholesterol and calcium can build up into 'plaques' in the arteries, causing narrowings or even blockages. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stable Angina, Coronary Artery Disease
- What is being tested?
- PET-CT
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2020to 10 Oct 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable angina patients with known coronary artery disease referred for further invasive assessment as part of routine clincal care
Who may be able to join
- Age ≥40
- Stable angina, defined as typical symptoms with evidence of reversible ischemia in non-invasive test and/or documented obstructive coronary artery disease on coronary angiography
- Patient that is willing and can provide written informed consent.
Who cannot join
- Acute coronary syndrome within <3 months
- Pregnancy
- Estimated glomerular filtration rate (eGFR) <60ml/min/1.73m²
- Previous bypass surgery
- Decompensated heart failure, or left ventricular ejection fraction less than 30%
- Patient allergic to contrast or cannot receive treatment with aspirin, heparin, or thienopyridines
Show all 11Show fewer
- Anticipated life expectancy <2 years
- Flow limiting coronary artery disease in the proximal segments of all the 3 epicardial coronaries
- History of heart transplantation
- Patient that requires surgical revascularization
- Extensive coronary artery disease (i.e., multiple chronic total occlusions) or tortuous coronary anatomy that does not allow assessment of the
Trial locations and contacts
1 site in 1 country.
About this study
Imaging the inside of coronary arteries (intravascular imaging) offers great insight into the assessment and treatment of coronary artery disease. Over time, substances such as fat, cholesterol and calcium can build up into 'plaques' in the arteries, causing narrowings or even blockages. These plaques can also rupture, causing cardiovascular events such as heart attacks or strokes. By using ultrasound and infrared technology, intravascular imaging can help assess these plaques, however this is an invasive technique involving angiography. Plaque composition, structure and stability can be affected by inflammation and the stress that the arteries are under. The investigators have pioneered novel minimally-invasive methods for modelling arterial stress using computed tomography coronary angiography (CTCA), as well as imaging coronary arterial inflammation using a positron emission tomography (PET) scan. Before embarking upon a large-scale clinical outcome study to determine whether these novel methods can improve risk prediction, the aim is to perform a proof-of-principle study to further develop our methodology for hybrid image analysis, and to validate this technique against high-resolution intravascular imaging as a surrogate marker of histology.
- Conditions
- Stable Angina, Coronary Artery Disease
- Being tested
- PET-CT
- Keywords
- Intravascular Ultrasound, Near Infrared Spectroscopy, Positron Emission Tomography
- Medical subject headings
- Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CTDiagnostic test
PET-CT compared to intravascular imaging for assessment of atherosclerotic plaques in stable angina patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Faesibility of co-registration of CTCA and PET-CT data
All studied vessels will be dividen into 3 mm segments and the CTCA and PET-CT studies will be co-registered electronically. The faesibility of this will be reported
Measured: 12 months
Secondary outcomes (4)
Comparing PET-CT, CTCA and intravascular imaging: plaque volume
The co-registered vessels will be dividen into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare estimations of plaque burden expressed as volume
Measured: 12 months
Comparing PET-CT, CTCA and intravascular imaging: plaque composition
The co-registered vessels will be dividen into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare estimations of plaque composition (reported as type of plaque)
Measured: 12 months
Comparing PET-CT, CTCA and intravascular imaging: haemodynamic forces
The co-registered vessels will be divided into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare estimations of haemodynamic forces including plaque and endothelial shear stress
Measured: 12 months
Comparing PET-CT, CTCA and intravascular imaging: presence of inflammation
The co-registered vessels will be divided into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare assessment of markers of inflammation and vulnerability in the plaques identified
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Nov 2020
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205110
- Sponsor's protocol ID
- 19/LO/1086
- Acronym
- VALID-PET-CT
- Status last verified
- Feb 2025
- First submitted
- 13 Dec 2019
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Fast, Semi-Automated Hybrid Imaging Platform to Assess Coronary Atherosclerotic Plaque Morphology, Endothelial Shear Stress and Arterial Inflammation: A Proof of Principle Study (VALID-PET-CT)
- ClinicalTrials.gov ID
- NCT04205110
- Acronym / sponsor ID
- VALID-PET-CT / 19/LO/1086
- Conditions
- Stable Angina, Coronary Artery Disease
- Keywords
- Intravascular Ultrasound, Near Infrared Spectroscopy, Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 19 Dec 2019 (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.
Imaging the inside of coronary arteries (intravascular imaging) offers great insight into the assessment and treatment of coronary artery disease. Over time, substances such as fat, cholesterol and calcium can build up into 'plaques' in the arteries, causing narrowings or even blockages. These plaques can also rupture, causing cardiovascular events such as heart attacks or strokes. By using ultrasound and infrared technology, intravascular imaging can help assess these plaques, however this is an invasive technique involving angiography. Plaque composition, structure and stability can be affected by inflammation and the stress that the arteries are under. The investigators have pioneered novel minimally-invasive methods for modelling arterial stress using computed tomography coronary angiography (CTCA), as well as imaging coronary arterial inflammation using a positron emission tomography (PET) scan. Before embarking upon a large-scale clinical outcome study to determine whether these novel methods can improve risk prediction, the aim is to perform a proof-of-principle study to further develop our methodology for hybrid image analysis, and to validate this technique against high-resolution intravascular imaging as a surrogate marker of histology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable angina patients with known coronary artery disease referred for further invasive assessment as part of routine clincal care
Key inclusion criteria (3 listed)
- Age ≥40
- Stable angina, defined as typical symptoms with evidence of reversible ischemia in non-invasive test and/or documented obstructive coronary artery disease on coronary angiography
- Patient that is willing and can provide written informed consent.
Key exclusion criteria (11 listed)
- Acute coronary syndrome within <3 months
- Pregnancy
- Estimated glomerular filtration rate (eGFR) <60ml/min/1.73m²
- Previous bypass surgery
- Decompensated heart failure, or left ventricular ejection fraction less than 30%
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 |
|---|---|---|
| PET-CTPET-CT compared to intravascular imaging for assessment of atherosclerotic plaques in stable angina patients | Diagnostic test | – |
Primary outcome
Faesibility of co-registration of CTCA and PET-CT data
Time frame: 12 months
All studied vessels will be dividen into 3 mm segments and the CTCA and PET-CT studies will be co-registered electronically. The faesibility of this will be reported
4 secondary outcomes
Comparing PET-CT, CTCA and intravascular imaging: plaque volume
Time frame: 12 months
Comparing PET-CT, CTCA and intravascular imaging: plaque composition
Time frame: 12 months
Comparing PET-CT, CTCA and intravascular imaging: haemodynamic forces
Time frame: 12 months
Comparing PET-CT, CTCA and intravascular imaging: presence of inflammation
Time frame: 12 months
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 6 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Stable Angina
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stable Angina and Coronary Artery Disease, run by Barts & The London NHS Trust 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 3 inclusion and 11 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 6 Feb 2025. 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?
Faesibility of co-registration of CTCA and PET-CT data (time frame: 12 months). 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 6 Feb 2025.