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出境医 / 临床实验 / Peripheral Vascular Disease and Coronary Artery Disease
Peripheral Vascular Disease and Coronary Artery Disease
Study Description
Brief Summary:
This study aims at evaluating the relationship between peripheral artery plaque characteristics evaluated by ultrasound and coronary culprit lesion characteristics evaluated by OCT in ACS patients.
| Condition or disease |
|---|
| Acute Coronary Syndrome |
Detailed Description:
Patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) and optical coherence tomography (OCT) are included in this study. Two skillful echocardiographers will evaluate peripheral artery plaque characteristics by ultrasound.Ultrasound parameters of peripheral artery will be compared among patients with different coronary culprit lesion characteristics, such as plaque rupture and plaque erosion.
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 350 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Relationship Between Peripheral Artery Plaque Characteristics Evaluated by Ultrasound and Coronary Culprit Lesion Characteristics Evaluated by OCT in ACS Patients |
| Actual Study Start Date : | November 8, 2018 |
| Actual Primary Completion Date : | December 31, 2019 |
| Actual Study Completion Date : | December 31, 2019 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Differences in ultrasound parameters of peripheral artery plaque according to different coronary culprit lesion morphology. [ Time Frame: Baseline ]Plaque rupture is characterized by the presence of fibrous cap discontinuity with a cavity formation. plaque erosion is characterized by the presence of the attached thrombus overlying an intact and visual plaque, luminal surface irregularity at the culprit lesion in the absence of thrombus, or attenuation of the underlying plaque by thrombus without superficial lipid or calcification immediately proximal or distal to the site of thrombus.Patients with plaque erosion have less plaques, lower intima-media thickness (IMT), lower plaque score (PS) compared to patients with plaque rupture.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
ACS patients
Criteria
Inclusion Criteria:
- Diagnosed as ACS underwent coronary angiography and OCT examination
- Agreed to accept peripheral artery ultrasound examination
Exclusion Criteria:
- In-stent restenosis, coronary dissection, coronary spam, thrombus
- left main artery disease
- Age>85 years old
- Cardiogenic shock or stroke admission
- Severe hepatic or renal dysfunction
- Poor quality of OCT image or massive thrombus
Contacts and Locations
Locations
| China, Heilongjiang | |
| The Second Affiliated Hospital of Harbin Medical University | |
| Harbin, Heilongjiang, China, 150081 | |
Sponsors and Collaborators
Harbin Medical University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 30, 2019 | ||||
| First Posted Date | June 3, 2019 | ||||
| Last Update Posted Date | September 16, 2020 | ||||
| Actual Study Start Date | November 8, 2018 | ||||
| Actual Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Differences in ultrasound parameters of peripheral artery plaque according to different coronary culprit lesion morphology. [ Time Frame: Baseline ] Plaque rupture is characterized by the presence of fibrous cap discontinuity with a cavity formation. plaque erosion is characterized by the presence of the attached thrombus overlying an intact and visual plaque, luminal surface irregularity at the culprit lesion in the absence of thrombus, or attenuation of the underlying plaque by thrombus without superficial lipid or calcification immediately proximal or distal to the site of thrombus.Patients with plaque erosion have less plaques, lower intima-media thickness (IMT), lower plaque score (PS) compared to patients with plaque rupture.
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Peripheral Vascular Disease and Coronary Artery Disease | ||||
| Official Title | The Relationship Between Peripheral Artery Plaque Characteristics Evaluated by Ultrasound and Coronary Culprit Lesion Characteristics Evaluated by OCT in ACS Patients | ||||
| Brief Summary | This study aims at evaluating the relationship between peripheral artery plaque characteristics evaluated by ultrasound and coronary culprit lesion characteristics evaluated by OCT in ACS patients. | ||||
| Detailed Description | Patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) and optical coherence tomography (OCT) are included in this study. Two skillful echocardiographers will evaluate peripheral artery plaque characteristics by ultrasound.Ultrasound parameters of peripheral artery will be compared among patients with different coronary culprit lesion characteristics, such as plaque rupture and plaque erosion. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | ACS patients | ||||
| Condition | Acute Coronary Syndrome | ||||
| Intervention | Not Provided | ||||
| 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 | Completed | ||||
| Actual Enrollment |
350 | ||||
| Original Estimated Enrollment |
400 | ||||
| Actual Study Completion Date | December 31, 2019 | ||||
| Actual Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 85 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03971864 | ||||
| Other Study ID Numbers | HMUOCT-PAU | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Yu Bo, Harbin Medical University | ||||
| Study Sponsor | Harbin Medical University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Harbin Medical University | ||||
| Verification Date | September 2020 | ||||
