Coronary Heart Disease (CHD)NCT06649305
A Prospective Multicenter Clinical Study： IntracOronary neaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary vulNerable Plaque in Patients With diabeTes
An observational study of Coronary Heart Disease (CHD) and Diabetes (DM), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
To evaluate the correlation between maxLCBI4mm/FCTmin(a new index of lipid plaque based on NIRS-OCT technology) and fiber cap thickness , and the prognosis of patients, providing a new quantitative index for early, accurate and comprehensive identification of vulnerable plaques, and exploring preventive measures for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease (CHD), Diabetes (DM)
- How many people
- 1,516 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 30 Sep 2027
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years old or older ，with diabetes requiring an OCT examination or treatment under OCT guidance
Who may be able to join
- 18 years old or older, gender is not limited
- Patients with diabetes who require an OCT examination or treatment under OCT guidance (diabetes definition: active treatment with insulin or oral hypoglycemic agents at admission). For patients with diabetes who are treated with diet only, abnormal fasting blood sugar (>7 mmol/l), blood sugar >11.1 mmol/l at any time, or abnormal glucose tolerance tests based on World Health Organization standards need to be recorded.
- Be able to understand the purpose of clinical research, voluntarily participate can complete the observation as required and sign the informed consent form
- 5: Lesion stenosis greater than or equal to 50% without interventional treatment
- 6: The diameter of the blood vessel in the diseased segment is greater than or equal to 2.5 mm
Who cannot join
- 1: Severe coagulation dysfunction (APTT greater than 3 times the upper limit of the normal range)
- 2: Severe hemodynamic disorder or shock that cannot be corrected
- 3: Patients with renal impairment（eGFR<30 mL/min/1.73m2）
- 4: Severe symptoms of heart failure (NYHA III and above) or left ventricular ejection fraction <30%
- 5: The presence or suspected presence of infective endocarditis or systemic active infection
- 6: Patients with refractory ventricular arrhythmias who have previously undergone coronary bypass transplantation (CABG) or plan to undergo CABG during the study
Show all 12Show fewer
- 7: Patients with serious concurrent diseases such as advanced cancer have a life expectancy of less than 24 months
- 8: Pregnant or lactating women, have a family plan within 24 months or are unwilling to take effective contraceptive measures
- 9: The target vessel has severe calcification or severe tortuosity, which cannot be examined by OCT
- 10: Have participated in other clinical trials or are participating in other drug/device clinical trials within 3 months prior to enrollment and have not met the primary endpoint
- 11: Investigators believe that those who are unnecessary for OCT or not suitable for inclusion in this trial.
- 12: There are multiple lesions in the same blood vessel, and the non-target lesion distance requiring treatment vascular segment is less than 5mm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Chenguang Li, Doctor, 86-13816767665, li.chenguang@zs-hospital.sh.cn
Rende Xu, Doctor, 86-15800624206, xu.rende@zs-hospital.sh.cn
About this study
Official title: A Prospective Multicenter Clinical Study：IntracOnary neaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary vulNerable Plaque in Patients With diabeTes
To evaluate the correlation between maxLCBI4mm/FCTmin(a new index of lipid plaque based on NIRS-OCT technology) and fiber cap thickness , and the prognosis of patients, providing a new quantitative index for early, accurate and comprehensive identification of vulnerable plaques, and exploring preventive measures for adverse events such as cardiac death and recurrent myocardial infarction caused by vulnerable plaques, so as to improve the long-term prognosis of patients.
- Conditions
- Coronary Heart Disease (CHD), Diabetes (DM)
- Keywords
- near-infrared spectroscopy
- Medical subject headings
- Coronary Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | NIRS-OCT examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE events in the 24 months after operation
record the MACE events (cardiac death, myocardial infarction, progressive angina, revascularization) after operation in 24 months
Measured: 24 months after operation
Secondary outcomes (2)
The maxLCBI4mm/FCTmin ratio
The maxLCBI4mm/FCTmin ratio is higher than 400/75
Measured: 24 months after operation
The maxLCBI4mm/FCTmin ratio
The maxLCBI4mm/FCTmin ratio can be used as a continuous indicator
Measured: 24 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start30 Oct 2024
- Primary completion15 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies 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
- 1,516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649305
- Sponsor's protocol ID
- ORIENT
- Status last verified
- Jan 2026
- First submitted
- 17 Oct 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided