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出境医 / 临床实验 / Role of Intracoronary Imaging in Plaque Identification
Role of Intracoronary Imaging in Plaque Identification
Study Description
Brief Summary:
NSTE-ACS patients are more likely to exhibit high-risk plaque characteristics in non-culprit lesions. Both IVUS and OCT imaging techniques interact in a complementary manner to provide morphological characterization of the atherosclerotic coronary plaques and help identification of high-risk vulnerable plaques. Using morphological parameters obtained from OCT and IVUS, a new plaque vulnerability score will be established for more precise definition of the most vulnerable plaques that carry the greatest risk of rupture and subsequent detrimental clinical outcomes in the future. Such score might help in targeting these plaques with certain therapeutic interventions aiming to their stabilization.
| Condition or disease | Intervention/treatment |
|---|---|
| Coronary Artery Disease | Diagnostic Test: intracoronary imaging (IVUS, OCT) |
Detailed Description:
Patients with NSTE-ACS presented to the study site fulfilling the eligibility criteria during enrollment period of 1 year. The culprit lesion(s) being responsible for the acute event will be revascularized by percutaneous coronary intervention (PCI). Both OCT (OPTISTM, St. Jude Medical Inc., St. Paul, MN, USA) and IVUS (Boston Scientific iLabTM Ultrasound Imaging System, MA, USA) will be performed after PCI to examine the non-culprit lesion(s) for detection of atherosclerotic plaques with the morphological characteristics consistent with high-risk plaques, namely "Vulnerable plaques". Plaque characteristics from IVUS and OCT imaging will be merged to establish novel scores, which help improve diagnostic accuracy for detection of high-risk lesions. Correlations IVUS and OCT images will be performed to identify most reliable factors associated with plaque vulnerability.Patients will be followed up to 6 months after PCI for detection of major adverse cardiovascular outcomes (MACE) after ischaemia-driven revascularization of the culprit lesion(s).
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 0 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Integrated Role of Intravascular Ultrasound and Optical Coherence Tomography to Define a New Plaque Vulnerability Score: A Pilot Study in Non STE-ACS |
| Actual Study Start Date : | April 1, 2019 |
| Estimated Primary Completion Date : | November 30, 2020 |
| Estimated Study Completion Date : | March 1, 2021 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Establishment of a new plaque vulnerability score to define vulnerable plaques by IVUS and OCT imaging. [ Time Frame: 1 year-duration ]Retrospective analysis of the collected OCT and IVUS data
Secondary Outcome Measures :
- Correlation between OCT and IVUS findings and the new score [ Time Frame: 6 months ]
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | May 14, 2019 | ||||||
| First Posted Date | May 16, 2019 | ||||||
| Last Update Posted Date | January 22, 2020 | ||||||
| Actual Study Start Date | April 1, 2019 | ||||||
| Estimated Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
Establishment of a new plaque vulnerability score to define vulnerable plaques by IVUS and OCT imaging. [ Time Frame: 1 year-duration ] Retrospective analysis of the collected OCT and IVUS data
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| Original Primary Outcome Measures |
Establishment of a new plaque vulnerability score to define vulnerable plaques by IVUS and OCT imaging. [ Time Frame: 1 year-duration ] IVUS and OCT Images will be examined for any identified atherosclerotic plaque.
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| Change History | |||||||
| Current Secondary Outcome Measures |
Correlation between OCT and IVUS findings and the new score [ Time Frame: 6 months ] | ||||||
| Original Secondary Outcome Measures |
Hypothesis generation that could correlate this new plaque vulnerability score with the clinical outcomes after the follow up period. [ Time Frame: 6 months ] Clinical outcomes in form of MACE
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Role of Intracoronary Imaging in Plaque Identification | ||||||
| Official Title | Integrated Role of Intravascular Ultrasound and Optical Coherence Tomography to Define a New Plaque Vulnerability Score: A Pilot Study in Non STE-ACS | ||||||
| Brief Summary | NSTE-ACS patients are more likely to exhibit high-risk plaque characteristics in non-culprit lesions. Both IVUS and OCT imaging techniques interact in a complementary manner to provide morphological characterization of the atherosclerotic coronary plaques and help identification of high-risk vulnerable plaques. Using morphological parameters obtained from OCT and IVUS, a new plaque vulnerability score will be established for more precise definition of the most vulnerable plaques that carry the greatest risk of rupture and subsequent detrimental clinical outcomes in the future. Such score might help in targeting these plaques with certain therapeutic interventions aiming to their stabilization. | ||||||
| Detailed Description | Patients with NSTE-ACS presented to the study site fulfilling the eligibility criteria during enrollment period of 1 year. The culprit lesion(s) being responsible for the acute event will be revascularized by percutaneous coronary intervention (PCI). Both OCT (OPTISTM, St. Jude Medical Inc., St. Paul, MN, USA) and IVUS (Boston Scientific iLabTM Ultrasound Imaging System, MA, USA) will be performed after PCI to examine the non-culprit lesion(s) for detection of atherosclerotic plaques with the morphological characteristics consistent with high-risk plaques, namely "Vulnerable plaques". Plaque characteristics from IVUS and OCT imaging will be merged to establish novel scores, which help improve diagnostic accuracy for detection of high-risk lesions. Correlations IVUS and OCT images will be performed to identify most reliable factors associated with plaque vulnerability.Patients will be followed up to 6 months after PCI for detection of major adverse cardiovascular outcomes (MACE) after ischaemia-driven revascularization of the culprit lesion(s). | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Probability Sample | ||||||
| Study Population |
The study subjects are patients with history of non-ST elevation acute coronary syndrome (NSTE-ACS): • *Diagnosis of NSTE-ACS: history of prolonged anginal pain (more 20 min) at rest, or recent instability of previously stable angina pectoris (at least Canadian Society Cardiovascular angina class III), or post-MI angina, together with ST segment or T wave changes. According to the results of cardiac biomarker, NSTE-ACS is subdivided into: NSTEMI (with +ve cardiac biomarkers) and unstable angina (with -ve cardiac biomarkers). |
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| Condition | Coronary Artery Disease | ||||||
| Intervention | Diagnostic Test: intracoronary imaging (IVUS, OCT)
Patients presenting with non STE-ACS will be subjected after performing PCI of the culprit lesion to intracoronary imaging with the help of IVUS and OCT of the non-culprit lesions to detect and image the so-called vulnerable plaques
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| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Withdrawn | ||||||
| Actual Enrollment |
0 | ||||||
| Original Estimated Enrollment |
35 | ||||||
| Estimated Study Completion Date | March 1, 2021 | ||||||
| Estimated Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | No formal inclusion or exclusion criteria | ||||||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | Not Provided | ||||||
| Removed Location Countries | Germany | ||||||
| Administrative Information | |||||||
| NCT Number | NCT03953040 | ||||||
| Other Study ID Numbers | OCTIVUS2019 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Ayat Aboutaleb Abdellah Abdelgalil, Assiut University | ||||||
| Study Sponsor | Assiut University | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Assiut University | ||||||
| Verification Date | January 2020 | ||||||
