Type 2 Diabetes MellitusPhase 4ACCREDITNCT01254552

Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis

A Phase 4 study testing iobitridol and gadoterate meglumine in people with Type 2 Diabetes Mellitus and Coronary Atherosclerosis, run by Guerbet at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study aimed to prospectively investigate the prevalence of myocardial scar on Dotarem-enhanced Cardiovascular Magnetic Resonance Imaging (MRI) in asymptomatic patients with type-2 Diabetes Mellitus and to assess its correlation with subclinical coronary artery disease on Cardiac Computed Tomography Angiography… Read more about this study

Who is it for?: Ages 50 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus, Coronary Atherosclerosis
What is being tested?: iobitridol and gadoterate meglumine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 351 participants
Where: 1 siteSouth Korea
Study dates: Aug 2010to Oct 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient with onset of type 2 diabetes occurred at age 30 years or older
Patient between the ages of 50 and 75 years at enrolment time
Patient with at least two identified cardiac risk factors who will undergo a CMR and a CCTA examinations to evaluate his/her coronary and cardiac status

Who cannot join

Patient with angina pectoris or chest discomfort
Patient with stress test or invasive coronary angiography within the prior 3 years
Patient with history of myocardial infarction, overt non compensated heart failure, or coronary revascularization
Patient with hemodynamic instability.
Patient with a contraindication or intolerance to Beta-Blocker administration

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Asan Medical Center
Seoul

Other trials in South Korea

About this study

Official title: Assessment With Cardiac Computed Tomography Angiography (CCTA) and Magnetic Resonance Imaging (MRI) in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis

Read the detailed description

Patients underwent a cardiac MRI examination with Dotarem within 60 days after screening visit. The myocardial CCTA examination with Xenetix 350 was performed within 1 to 30 days (but no sooner than 24 hours) after the MRI examination.

Conditions: Type 2 Diabetes Mellitus, Coronary Atherosclerosis
Being tested: iobitridol, gadoterate meglumine
Medical subject headings: Diabetes Mellitus, Type 2, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iobitridolDrug
Also called Xenetix
Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration.
gadoterate meglumineDrug
Also called gadoteric acid, Dotarem
Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)

Study groups in NCT01254552
Study group	Role	What they receive
Dotarem and Xenetix 350	Experimental	Not described Receives: Drug: iobitridol; Drug: gadoterate meglumine

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus
Measured: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

Secondary outcomes (1)

Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis
The degree of coronary artery stenosis on CCTA was assessed according to the following scale:
- No stenosis: 0%
- Non significant stenosis: 1-50%
- Significant stenosis >50% and ≤99%
- Occlusion: 100%
Measured: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Oct 2016

First posted6 Dec 2010 (estimated)
Study startAug 2010
Primary completionSep 2011
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies 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: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01254552
Sponsor's protocol ID: ISO-44-011
Acronym: ACCREDIT
Status last verified: Feb 2019
First submitted: 13 Oct 2010
Last updated: 31 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment With Cardiac Computed Tomography Angiography (CCTA) and Magnetic Resonance Imaging (MRI) in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis
ClinicalTrials.gov ID: NCT01254552
Acronym / sponsor ID: ACCREDIT / ISO-44-011
Conditions: Type 2 Diabetes Mellitus, Coronary Atherosclerosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 351 participants (actual)
Lead sponsor: GuerbetIndustry (pharma, biotech, devices)
Study start: Aug 2010 (actual)
Primary completion: Sep 2011 (actual)
Study completion: Oct 2016 (actual)
First posted: 6 Dec 2010 (estimated)
Results: Posted 31 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dotarem and Xenetix 350	Experimental	Drug: iobitridol, Drug: gadoterate meglumine

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient with onset of type 2 diabetes occurred at age 30 years or older
Patient between the ages of 50 and 75 years at enrolment time
Patient with at least two identified cardiac risk factors who will undergo a CMR and a CCTA examinations to evaluate his/her coronary and cardiac status

Key exclusion criteria (5 listed)

Patient with angina pectoris or chest discomfort
Patient with stress test or invasive coronary angiography within the prior 3 years
Patient with history of myocardial infarction, overt non compensated heart failure, or coronary revascularization
Patient with hemodynamic instability.
Patient with a contraindication or intolerance to Beta-Blocker administration

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
iobitridolAlso: XenetixXenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration.	Drug	Dotarem and Xenetix 350
gadoterate meglumineAlso: gadoteric acid, DotaremDotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)	Drug	Dotarem and Xenetix 350

Primary outcome

Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus
Time frame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

1 secondary outcome

Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis
Time frame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

Results and safety

Results posted to the registry on 31 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dotarem and Xenetix 350	351	348

Primary outcome: Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus

Time frame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations). Count of participants. Unit: Participants

Measure	Intention To Treat Population n = 322
Value	23

Intention To Treat Population: rate: 0.071 (95% CI 0.043 to 0.100)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Between Dotarem and Xenetix 350 Injection	0 of 328 (0%)	8 of 328 (2.4%)	0 of 328
During Xenetix 350 Injection	0 of 328 (0%)	12 of 328 (3.7%)	0 of 328
After Xenetix 350 Injection	0 of 328 (0%)	7 of 328 (2.1%)	0 of 328

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

The record lists no contact. Use the official record to reach the sponsor.

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 iobitridol and gadoterate meglumine in people with Type 2 Diabetes Mellitus and Coronary Atherosclerosis, run by Guerbet at 1 site in South Korea.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 31 May 2019. 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 South Korea. 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?

Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus (time frame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)). 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 NCT01254552.

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 31 May 2019.