NCT06681155Not yet recruiting
Identification Of High-risk Coronary Plaques By Multimodal Intravascular Imaging
A Prospective Cohort Study on the Identification of High-Risk Coronary Plaque by Multimodality Intravascular Imaging(PlaqueVision Study)
Source: ClinicalTrials.gov · Last updated 8 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is a multicenter prospective observational clinical study, which will be conducted in 11 hospitals, and approximately 500 subjects will be enrolled. Plaque morphology and stability of non-culprit lesions were assessed by intravascular ultrasound (IVUS) and optical coherence tomography-near-infrared spectroscopy (OCT) after percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Plaques were grouped according to high-risk or non-high-risk. Clinical follow-up was conducted after PCI.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 7 Nov 2024
- Start date
- Nov 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06681155
What you commit to
- Study type: Observational
- Planned participants: 500
- From Nov 2024 to the primary completion date, Dec 2027
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Exclusion criteria for the clinical study:
- Cardiogenic shock or hemodynamic instability;
- History of coronary artery bypass grafting (CABG), or planned CABG;
- Severe renal impairment (glomerular filtration rate \<30ml/min/1.73m²);
- Life expectancy of less than 2 years;
- Currently participating in other ongoing investigative device or drug studies that have not yet reached their primary endpoints.
Other
- Imaging exclusion criteria:
- The anatomical structure of the non-culprit lesion is not suitable for intravascular imaging catheter imaging (lesions at the left main trunk or right coronary artery ostium, severe calcification, chronic total occlusion, etc.).
Who the study is looking for
- Inclusion criteria for the clinical study:
- Aged ≥18 years at enrollment, male or female;
- Meets the diagnosis of acute coronary syndrome, including acute myocardial infarction and unstable angina. Acute myocardial infarction includes ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (non-STEMI). STEMI is defined as chest pain lasting at least 30 minutes, arriving at the hospital within 12 hours from the onset of symptoms, changes in the 12-lead ECG (ST-segment elevation \>0.1 mV in ≥2 consecutive leads or new left bundle branch block), and elevated cardiac biomarkers (troponin T/I). Non-STEMI is defined as ischemic symptoms without ST-segment elevation on ECG, accompanied by elevated cardiac biomarkers. Unstable angina is defined as chest pain lasting 5-30 minutes at rest, or worsening of exertional angina, and accompanied by one of the following: transient ST-segment depression or elevation; coronary angiography showing luminal narrowing ≥90% or plaque rupture or thrombotic lesions.
- Planned to undergo coronary angiography and PCI treatment;
- Hemodynamically stable and able to tolerate repeated intracoronary administration of nitroglycerin;
- Capable of understanding the requirements of this study, willing to participate in the study, and have signed an informed consent form.
- Imaging inclusion criteria:
- Coronary angiography clearly shows that the patient has at least one non-culprit lesion with a visual assessment of diameter stenosis between 40-70%, and the operator believes that interventional treatment intervention is not temporarily necessary;
- The site of the non-culprit lesion has not previously had a stent implanted.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Jishuitan Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| People's Liberation Army General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Fuwai Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| China-Japan Union Hospital of JiLin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Second Affiliated Hospital, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| People's Hospital of Xinjiang Uygur Autonomous Region Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Wuhan Asian Heart Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Xi 'An Jiaotong University Second Affiliated Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.