Coronary PlaquesNCT02347306
Prospective Identification of High-risk Coronary Plaques Through Non-invasive Imaging
An observational study of Coronary Plaques, run by Papworth Hospital NHS Foundation Trust.
Trial summary
Cardiovascular disease remains the leading cause of death worldwide. Identifying individual patients at risk of a suture adverse events, including myocardial infractions (heart attacks), remains a major diagnostic challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Plaques
- What is being tested?
- Telephone interview
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2016
- 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: This study will be an observational, retrospective, single center cohort study based at Papworth Hospital NHS Trust, including up to a maximum of 100 patients. The patients have already been identified through their participation in a previous research study, as stated above. Additional inclusion criteria are; age >18 years and the ability to provide informed consent. The only exclusion criterion is the inability of the participant to provide informed consent.
Who may be able to join
- Age >18 years
- The ability to provide informed consent.
- Previously part of CTA accuracy validation study
Who cannot join
- The inability of the participant to provide informed consent
About this study
Cardiovascular disease remains the leading cause of death worldwide. Identifying individual patients at risk of a suture adverse events, including myocardial infractions (heart attacks), remains a major diagnostic challenge. Recent studies have shown that coronary plaques responsible for hear attack are composed of a large lipid core with a thin overlying fibrous cap. Although these features can be identified using invasive imaging modalities, non-invasive imaging options remain limited due to their poor spatial resolution. Recently the investigators have developed and validated a novel tool that will allow us to characterise coronary plaque composition based on dual source CT images. Our aim is to assess this tool within a cohort of patients who have already undergone a coronary CT as part of a previous study.
Read the detailed description
Reliable identification of coronary plaque at risk of causing future adverse cardiovascular events would allow patient-specific targeting of intensive therapy. The majority of events are precipitated by coronary plaque rupture, with ruptured plaques exhibiting a large necrotic, lipid core with superimposed thrombus. The proposed precursor lesion shares similar plaque compositional features to ruptured plaques but with a thin overlying fibrous cap and is termed a thin-cap fibroatheroma (TCFA)1. At present there is a major emphasis on imaging modalities that can identify these higher-risk plaque subtypes.
We have previously validated an invasive imaging modality, virtual-histology intravascular ultrasound (VH-IVUS) against histology, and found that VH-IVUS identified TCFA with a diagnostic accuracy of 74%2. In prospective studies, VH-defined TCFAs were associated with a 7x greater risk of future events than other plaque subtypes3. Although this technique shows promise in permitting plaque-based risk stratification, it is limited by its invasive nature. Thus, alternate, non-invasive imaging options are required for more widespread risk assessment.
Recently, we have devised a novel method of creating "Plaque Maps" using CT attenuation data individualised to each patient (Figure 1), which permits identification of coronary plaque components with a diagnostic accuracy of 75%-85%4. However, whilst CT Plaque Maps could identify fibroatheroma with similar diagnostic accuracy to VH-IVUS (79% vs. 74%), the spatial resolution of CT was unable to detect the thin fibrous cap and distinguish fibroatheroma from TCFA (Figure 2). More recently we have introduced necrotic core/fibrous plaque ratio as a possible Plaque Map surrogate for identification of TCFA. Using a ratio of >0.58, the sensitivity to detect a TCFA was 84% and specificity 75%; an improvement over all previously identified CT-defined features of high risk plaques4. Whether this novel strategy can prospectively improve identification of plaque vulnerability is unproven.
- Conditions
- Coronary Plaques
- Being tested
- Telephone interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone interviewOther
| Study group | Role | What they receive |
|---|---|---|
| cohort of patients with suspected coronary artery disease | a cohort of patients with suspected coronary artery disease going forward for conventional angiography and (2) whether CT-TCFA is associated with future adverse cardiovascular events. Receives: Other: Telephone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT-defined TCFA association with future adverse cardiovascular events
Measured: 7 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary PlaquesStudies 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
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347306
- Sponsor's protocol ID
- P01987 Protocol 1.0 September
- Status last verified
- Jan 2015
- First submitted
- 7 Jan 2015
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Identification of High-risk Coronary Plaques Through Non-invasive Imaging
- ClinicalTrials.gov ID
- NCT02347306
- Acronym / sponsor ID
- P01987 Protocol 1.0 September
- Conditions
- Coronary Plaques
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 27 Jan 2015 (estimated)
- 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 remains the leading cause of death worldwide. Identifying individual patients at risk of a suture adverse events, including myocardial infractions (heart attacks), remains a major diagnostic challenge. Recent studies have shown that coronary plaques responsible for hear attack are composed of a large lipid core with a thin overlying fibrous cap. Although these features can be identified using invasive imaging modalities, non-invasive imaging options remain limited due to their poor spatial resolution. Recently the investigators have developed and validated a novel tool that will allow us to characterise coronary plaque composition based on dual source CT images. Our aim is to assess this tool within a cohort of patients who have already undergone a coronary CT as part of a previous study.
Detailed description
Reliable identification of coronary plaque at risk of causing future adverse cardiovascular events would allow patient-specific targeting of intensive therapy. The majority of events are precipitated by coronary plaque rupture, with ruptured plaques exhibiting a large necrotic, lipid core with superimposed thrombus. The proposed precursor lesion shares similar plaque compositional features to ruptured plaques but with a thin overlying fibrous cap and is termed a thin-cap fibroatheroma (TCFA)1. At present there is a major emphasis on imaging modalities that can identify these higher-risk plaque subtypes.
We have previously validated an invasive imaging modality, virtual-histology intravascular ultrasound (VH-IVUS) against histology, and found that VH-IVUS identified TCFA with a diagnostic accuracy of 74%2. In prospective studies, VH-defined TCFAs were associated with a 7x greater risk of future events than other plaque subtypes3. Although this technique shows promise in permitting plaque-based risk stratification, it is limited by its invasive nature. Thus, alternate, non-invasive imaging options are required for more widespread risk assessment.
Recently, we have devised a novel method of creating "Plaque Maps" using CT attenuation data individualised to each patient (Figure 1), which permits identification of coronary plaque components with a diagnostic accuracy of 75%-85%4. However, whilst CT Plaque Maps could identify fibroatheroma with similar diagnostic accuracy to VH-IVUS (79% vs. 74%), the spatial resolution of CT was unable to detect the thin fibrous cap and distinguish fibroatheroma from TCFA (Figure 2). More recently we have introduced necrotic core/fibrous plaque ratio as a possible Plaque Map surrogate for identification of TCFA. Using a ratio of >0.58, the sensitivity to detect a TCFA was 84% and specificity 75%; an improvement over all previously identified CT-defined features of high risk plaques4. Whether this novel strategy can prospectively improve identification of plaque vulnerability is unproven.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort of patients with suspected coronary artery disease | – | Other: Telephone interviewa cohort of patients with suspected coronary artery disease going forward for conventional angiography and (2) whether CT-TCFA is associated with future adverse cardiovascular events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be an observational, retrospective, single center cohort study based at Papworth Hospital NHS Trust, including up to a maximum of 100 patients. The patients have already been identified through their participation in a previous research study, as stated above. Additional inclusion criteria are; age >18 years and the ability to provide informed consent. The only exclusion criterion is the inability of the participant to provide informed consent.
Key inclusion criteria (3 listed)
- Age >18 years
- The ability to provide informed consent.
- Previously part of CTA accuracy validation study
Key exclusion criteria (1 listed)
- The inability of the participant to provide informed consent
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 |
|---|---|---|
| Telephone interview | Other | cohort of patients with suspected coronary artery disease |
Primary outcome
CT-defined TCFA association with future adverse cardiovascular events
Time frame: 7 years post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Plaques, run by Papworth Hospital NHS Foundation Trust.
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 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: status not confirmed, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
CT-defined TCFA association with future adverse cardiovascular events (time frame: 7 years post surgery). 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 27 Jan 2015.