Atheroma Progression and Vulnerability Under Continuous Glucose Monitoring (NCT04559191) | Clinical Trial Compass
UnknownPhase 4
Atheroma Progression and Vulnerability Under Continuous Glucose Monitoring
Japan90 participantsStarted 2019-03-01
Plain-language summary
The OPTIMAL is a single-center, randomized trial to evaluate the efficacy of CGM-based glycemic control on atheroma progression in T2DM patients with CAD by using serial intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) imaging. A total of 90 eligible subjects will be randomized 1:1 into 2 groups to receive either CGM-based glycemic control or HbA1c-baded glycemic management. Coronary angiography and NIRS/IVUS imaging is repeated at the end of the assigned treatment period.
Results: The primary endpoint is the normalized absolute change in total atheroma volume from baseline to 12 months. The secondary endpoints include (1) the absolute change in percent atheroma volume, (2) the percent change in lipid core burden index, (3) the change in coefficient variance measured by CGM, (4) the change in atherogenic markers (high-density lipoprotein functionality, proprotein convertase subxilisin/kexin type 9 and fatty-acid binding proteins), and (5) the frequency of hypoglycemia. Safety will also be evaluated.
Who can participate
Age range
20 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male of female between 20 and 85 years of age
* Type 2 diabetic patients with coronary artery disease who require PCI
* The presence of mild stenosis in the non-target vessel (% diameter stenosis between 10-50%)
* 7.0 ≤ HbA1c ≤ 10.0%
* HbA1c ≤ 10.0% in subjects who receive insulin, sulfonylurea or nateglinide
* Ability to understand the requirements of the study and to provide informed consent
Exclusion Criteria:
* very tortuous coronary artery and/or severe calcification which is unsuitable for intravascular imaging
* Subjects with severe renal dysfunction (estimated glomerular filtration rate \< 40 mL/min/1.73m2)
* the absence of any atherosclerotic lesions in the non-target vessel those who take PCSK9 inhibitor
* current enrolment in another investing device or drug study pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the normalized absolute change in total atheroma volume on serial intravascular ultrasound imaging.
Timeframe: from baseline to 12 months
Trial details
NCT IDNCT04559191
SponsorNational Cerebral and Cardiovascular Center, Japan