Ignite Creation Date:
2024-05-06 @ 3:39 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02347306
Status:
UNKNOWN
Last Update Posted:
2015-01-27
First Post:
2015-01-07
Brief Title:
Prospective Identification of High-risk Coronary Plaques Through Non-invasive Imaging
Sponsor:
Papworth Hospital NHS Foundation Trust
Organization:
Papworth Hospital NHS Foundation Trust
Study Overview
Official Title:
Prospective Identification of High-risk Coronary Plaques Through Non-invasive Imaging
Status:
UNKNOWN
Status Verified Date:
2015-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 TCFA1 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 742 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 75-854 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 corefibrous plaque ratio as a possible Plaque Map surrogate for identification of TCFA Using a ratio of 058 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
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 742 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 75-854 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 corefibrous plaque ratio as a possible Plaque Map surrogate for identification of TCFA Using a ratio of 058 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None