Coronary AtherosclerosisPhase 4OPTIMALNCT04559191
Atheroma Progression and Vulnerability Under Continuous Glucose Monitoring
A Phase 4 study testing continuous glucose monitoring (CGM) in people with Coronary Atherosclerosis, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Coronary Atherosclerosis
- What is being tested?
- continuous glucose monitoring (CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteJapan
- Study dates
- 1 Mar 2019to 31 Mar 2022
- Phase
- Phase 4
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
National Cerebral & Cardiovascular Center
Suita, 5648565
Yu Kataoka, MD, +81661701070 ext. 60189, yu.kataoka@ncvc.go.jp
About this study
Official title: The Efficacy of Glycemic Control With Continuous Glucose Monitoring on Atheroma Progression: Rationale and Design of the Observation of Coronary Atheroma Progression Under Continuous Glucose Monitoring Guidance in Patients With Type 2 Diabetes Mellitus
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.
Read the detailed description
Enrollment of 90 patients is planned at National Cerebral \& Cardiovascular Center in Japan. Study participants are randomly assigned to either CGM-based glucose management or HbA1c-based glucose management.
Eligible subjects should have CAD requiring elective PCI. HbA1c at screening should be between 7.0 and 10.0%.
Non-culprit vessel with its severe tortuousty and/or calcification will be excluded. Subjects with baseline estimated glomerular filtration rate <40 mL/min/1.73m2 will not be eligible.
After informed consent has been obtained, elective PCI will be conducted to treat culprit lesion. NIRS/IVUS imaging will be conducted to evaluate coronary atheroma.
In the CGM-based glucose management group, CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States) and HbA1c measurement will be undertaken at baseline and 3, 6, 9 and 12 months following PCI. In the HbA1c-based glucose management group, HbA1c will be measured at baseline and 3, 6, 9 and 12 months after PCI, and CGM will be used at baseline and 12 months in a similar fashion..
With regard to the use of anti-diabetic drugs, in the CGM-guided glycemic control group, endocrinologist will select glucose lowering drugs to fulfill the following CGM-derived goals: (a) the frequency of hypoglycemia=0%, (b) the coefficient of variation <36% and (c) averaged glucose level between 70-180 mg/dl.6 If the frequency of hypoglycemia is over 10% and/or the averaged glucose level is more than 400 mg/dl, patients will be asked to visit within 1 month after CGM measurement. In the HbA1c-guided therapy group, the selection of glucose lowering agents will be made according to the discretion of each endocrinologist to achieve HbA1c <7.0%.
At 12 months following PCI, patients will be hospitalized to take follow-up coronary angiography and intravascular imaging study. NIRS/IVUS imaging in the non-culprit vessel will be conducted again in a similar fashion.
- Conditions
- Coronary Atherosclerosis
- Being tested
- continuous glucose monitoring (CGM)
- Keywords
- type 2 diabetes mellitus, coronary atherosclerosis, intravascular ultrasound, near-infrared spectroscopy, continuous glucose monitoring
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous glucose monitoring (CGM)Device
CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States)
| Study group | Role | What they receive |
|---|---|---|
| HbA1c-guided group | No intervention | Glycemic control is controlled by guideline-recommended HbA1c control. |
| CGM-guided group | Active comparator | Glycemic control is controlled by CGM-guided control. Receives: Device: continuous glucose monitoring (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the normalized absolute change in total atheroma volume on serial intravascular ultrasound imaging.
This measure is analyzed by serial intravascular ultrasound imaging.
Measured: from baseline to 12 months
Secondary outcomes (6)
the absolute change in percent atheroma volume on serial intravascular ultrasound imaging.
This measure is analyzed by serial intravascular ultrasound imaging.
Measured: from baseline to 12 months
the percent change in lipid core burden index on serial near-infrared spectroscopy imaging.
This measure is analyzed by serial near-infrared spectroscopy imaging.
Measured: from baseline to 12 months
the change in coefficient variance evaluated by CGM
This measure is analyzed by CGM.
Measured: from baseline to 12 months
the correlation of change in concentration of serum proprotein convertase subxilisin/kexin type 9 with the normalized absolute change in total atheroma volume
The correlation of IVUS measure with concentration of serum proprotein convertase subxilisin/kexin type 9 is analyzed.
Measured: from baseline to 12 months
change in TAV under the use of specific anti-diabetic agents (dipeptidyl peptidase-4 inhibitors, sodium-glucose transport protein 2 inhibitors and glucagon-like peptide-1 agonists)
This measure is analyzed by serial intravascular ultrasound imaging.
Measured: from baseline to 12 months
the frequency of hypoglycemia
This event is collected through each clinical visit.
Measured: from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Mar 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
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 Coronary AtherosclerosisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cerebral and Cardiovascular Center, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Kataoka, National Cerebral and Cardiovascular Center, Japan
- Investigators
- Yu Kataoka, MD, Principal investigator, National Cerebral & Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559191
- Sponsor's protocol ID
- M30-152-2
- Acronym
- OPTIMAL
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kataoka Y, Hosoda K, Makino H, Matsubara M, Matsuo M, Ohata Y, Koezuka R, Tamanaha T, Tomita T, Honda-Kohmo K, Noguchi M, Son C, Nishimura K, Asaumi Y, Miyamoto Y, Noguchi T, Yasuda S. The efficacy of glycemic control with continuous glucose monitoring on atheroma progression: rationale and design of the Observation of Coronary Atheroma Progression under Continuous Glucose Monitoring Guidance in Patients with Type 2 Diabetes Mellitus (OPTIMAL). Cardiovasc Diagn Ther. 2019 Oct;9(5):431-438. doi: 10.21037/cdt.2019.09.02.
PubMed 31737515
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Glycemic Control With Continuous Glucose Monitoring on Atheroma Progression: Rationale and Design of the Observation of Coronary Atheroma Progression Under Continuous Glucose Monitoring Guidance in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04559191
- Acronym / sponsor ID
- OPTIMAL / M30-152-2
- Conditions
- Coronary Atherosclerosis
- Keywords
- type 2 diabetes mellitus, coronary atherosclerosis, intravascular ultrasound, near-infrared spectroscopy, continuous glucose monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cerebral and Cardiovascular Center, JapanUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 22 Sep 2020 (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.
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.
Detailed description
Enrollment of 90 patients is planned at National Cerebral \& Cardiovascular Center in Japan. Study participants are randomly assigned to either CGM-based glucose management or HbA1c-based glucose management.
Eligible subjects should have CAD requiring elective PCI. HbA1c at screening should be between 7.0 and 10.0%.
Non-culprit vessel with its severe tortuousty and/or calcification will be excluded. Subjects with baseline estimated glomerular filtration rate <40 mL/min/1.73m2 will not be eligible.
After informed consent has been obtained, elective PCI will be conducted to treat culprit lesion. NIRS/IVUS imaging will be conducted to evaluate coronary atheroma.
In the CGM-based glucose management group, CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States) and HbA1c measurement will be undertaken at baseline and 3, 6, 9 and 12 months following PCI. In the HbA1c-based glucose management group, HbA1c will be measured at baseline and 3, 6, 9 and 12 months after PCI, and CGM will be used at baseline and 12 months in a similar fashion..
With regard to the use of anti-diabetic drugs, in the CGM-guided glycemic control group, endocrinologist will select glucose lowering drugs to fulfill the following CGM-derived goals: (a) the frequency of hypoglycemia=0%, (b) the coefficient of variation <36% and (c) averaged glucose level between 70-180 mg/dl.6 If the frequency of hypoglycemia is over 10% and/or the averaged glucose level is more than 400 mg/dl, patients will be asked to visit within 1 month after CGM measurement. In the HbA1c-guided therapy group, the selection of glucose lowering agents will be made according to the discretion of each endocrinologist to achieve HbA1c <7.0%.
At 12 months following PCI, patients will be hospitalized to take follow-up coronary angiography and intravascular imaging study. NIRS/IVUS imaging in the non-culprit vessel will be conducted again in a similar fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HbA1c-guided group | No intervention | –Glycemic control is controlled by guideline-recommended HbA1c control. |
| CGM-guided group | Active comparator | Device: continuous glucose monitoring (CGM)Glycemic control is controlled by CGM-guided control. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous glucose monitoring (CGM)CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States) | Device | CGM-guided group |
Primary outcome
the normalized absolute change in total atheroma volume on serial intravascular ultrasound imaging.
Time frame: from baseline to 12 months
This measure is analyzed by serial intravascular ultrasound imaging.
6 secondary outcomes
the absolute change in percent atheroma volume on serial intravascular ultrasound imaging.
Time frame: from baseline to 12 months
the percent change in lipid core burden index on serial near-infrared spectroscopy imaging.
Time frame: from baseline to 12 months
the change in coefficient variance evaluated by CGM
Time frame: from baseline to 12 months
the correlation of change in concentration of serum proprotein convertase subxilisin/kexin type 9 with the normalized absolute change in total atheroma volume
Time frame: from baseline to 12 months
change in TAV under the use of specific anti-diabetic agents (dipeptidyl peptidase-4 inhibitors, sodium-glucose transport protein 2 inhibitors and glucagon-like peptide-1 agonists)
Time frame: from baseline to 12 months
the frequency of hypoglycemia
Time frame: from baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Results publication: PubMed 31737515Kataoka Y, Hosoda K, Makino H, Matsubara M, Matsuo M, Ohata Y, Koezuka R, Tamanaha T, Tomita T, Honda-Kohmo K, Noguchi M, Son C, Nishimura K, Asaumi Y, Miyamoto Y, Noguchi T, Yasuda S. The efficacy of glycemic control with continuous glucose monitoring on atheroma progression: rationale and design of the Observation of Coronary Atheroma Progression under Continuous Glucose Monitoring Guidance in Patients with Type 2 Diabetes Mellitus (OPTIMAL). Cardiovasc Diagn Ther. 2019 Oct;9(5):431-438. doi: 10.21037/cdt.2019.09.02.
- Individual participant dataSharing planned: Undecided
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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.
Yu Kataoka, MD principal investigator
National Cerebral & Cardiovascular Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing continuous glucose monitoring (CGM) in people with Coronary Atherosclerosis, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 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 Japan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Kataoka, MD (+81661701070 ext. 60189, yu.kataoka@ncvc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the normalized absolute change in total atheroma volume on serial intravascular ultrasound imaging. (time frame: from baseline to 12 months). 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 NCT04559191, 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 22 Sep 2020.