Can a new eye inside arteries predict heart attacks in diabetics?
NCT ID NCT06649305
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will use a special camera (NIRS-OCT) to look inside the heart arteries of 1,516 people with diabetes. The goal is to find fatty plaques that might rupture and cause heart attacks. Researchers hope to create a new way to identify these dangerous plaques early, so doctors can take steps to prevent future heart problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could provide a new imaging method to identify dangerous plaques early, potentially reducing heart attacks and cardiac deaths in diabetic patients.
- What could go wrong
- This is an observational study, not a treatment trial. It may not directly improve outcomes, and the new index needs validation before clinical use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,516 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients aged 18 years old or older ,with diabetes requiring an OCT examination or treatment under OCT guidance
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 18 years old or older, gender is not limited 2. 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. 3. 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 Exclusion Criteria: * 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongshan Hospital
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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