Acute Coronary SyndromeNCT03971864
Peripheral Vascular Disease and Coronary Artery Disease
An observational study of Acute Coronary Syndrome, run by Harbin Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2018to 31 Dec 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ACS patients
Who may be able to join
- Diagnosed as ACS underwent coronary angiography and OCT examination
- Agreed to accept peripheral artery ultrasound examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
About this study
Official title: The Relationship Between Peripheral Artery Plaque Characteristics Evaluated by Ultrasound and Coronary Culprit Lesion Characteristics Evaluated by OCT in ACS Patients
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in ultrasound parameters of peripheral artery plaque according to different coronary culprit lesion morphology.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start8 Nov 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971864
- Sponsor's protocol ID
- HMUOCT-PAU
- Status last verified
- Sep 2020
- First submitted
- 30 May 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weng Z, Zhao C, Qin Y, Liu C, Pan W, Hu S, He L, Xu Y, Zeng M, Feng X, Gao R, Yu X, Liu M, Yi B, Zhang D, Koniaeva E, Musin T, Mohammad D, Zhu B, Sun Y, Hou J, Tian J, Mintz GS, Jia H, Yu B. Peripheral atherosclerosis in acute coronary syndrome patients with plaque rupture vs plaque erosion: A prospective coronary optical coherence tomography and peripheral ultrasound study. Am Heart J. 2023 Sep;263:159-168. doi: 10.1016/j.ahj.2023.06.006. Epub 2023 Jun 14.
PubMed 37327980
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Peripheral Artery Plaque Characteristics Evaluated by Ultrasound and Coronary Culprit Lesion Characteristics Evaluated by OCT in ACS Patients
- ClinicalTrials.gov ID
- NCT03971864
- Acronym / sponsor ID
- HMUOCT-PAU
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Jun 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ACS patients
Key inclusion criteria (2 listed)
- Diagnosed as ACS underwent coronary angiography and OCT examination
- Agreed to accept peripheral artery ultrasound examination
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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 16 Sep 2020.
- Derived from this study: PubMed 37327980Weng Z, Zhao C, Qin Y, Liu C, Pan W, Hu S, He L, Xu Y, Zeng M, Feng X, Gao R, Yu X, Liu M, Yi B, Zhang D, Koniaeva E, Musin T, Mohammad D, Zhu B, Sun Y, Hou J, Tian J, Mintz GS, Jia H, Yu B. Peripheral atherosclerosis in acute coronary syndrome patients with plaque rupture vs plaque erosion: A prospective coronary optical coherence tomography and peripheral ultrasound study. Am Heart J. 2023 Sep;263:159-168. doi: 10.1016/j.ahj.2023.06.006. Epub 2023 Jun 14.
- Individual participant dataSharing planned: No
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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.
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 Acute Coronary Syndrome, run by Harbin Medical University at 1 site in China.
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 2 inclusion and 6 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 16 Sep 2020. 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 China. 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?
Differences in ultrasound parameters of peripheral artery plaque according to different coronary culprit lesion morphology. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03971864, which also lists 1 linked publication.
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 16 Sep 2020.