Type2 DiabetesCARPEDIEMNCT03016910
Coronary Artery Plaque Burden and Morphology in Type 2 Diabetes Mellitus.
An observational study of Type2 Diabetes and Atherosclerosis, run by Svendborg Hospital at 1 site in Denmark.
Trial summary
Unstable plaque, the primary cause of myocardial infarction, is characterized by distinct a morphology including positive remodeling (PR), low attenuated plaque (LAP), napkin ring sign (NRS), and spotty calcifications (SC) The purpose of the present study is to investigate the influence of microvascular dysfunction… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes, Atherosclerosis, Plaque, Atherosclerotic
- How many people
- 350 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2016to Sep 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with type 1 or 2 diabetes mellitus without history of CAD or relevant symptoms (angina). Patients are recruited at the out-patient clinic at Svendborg Hospital.
Who may be able to join
- Age > 18 years
- Type 1 or 2 diabetes mellitus
- Ability to provide informed conscent
Who cannot join
- History of CAD
- Symtoms of CAD (angina)
- Any tachyarrhythmias making CCTA impossible
- Glumerular filtration rate (GFR)< 45 ml/min
- Allergy to iodine contrast
- Critical illness with life expectancy less than 1 year
- Documented heart failure
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University Hospital of Odense (OUH) Svendborg Hospital
Svendborg, Fyn, 5700
Laurits J Heinsen, MD, +4563202429, lauritsheinsen@gmail.com
kenneth Egstrup, Prof. DMSci, +4563202402, kenneth.egstrup@rsyd.dk
About this study
Official title: Coronary Artery Plaque Burden in Type 2 Diabetes Mellitus. Changes Over Time, Relation to Risk Profile, and Comparison to Acute Myocardial Infarction.
Unstable plaque, the primary cause of myocardial infarction, is characterized by distinct a morphology including positive remodeling (PR), low attenuated plaque (LAP), napkin ring sign (NRS), and spotty calcifications (SC) The purpose of the present study is to investigate the influence of microvascular dysfunction and additional risk factors on plaque morphology and plaque burden in patients with diabetes mellitus.
Read the detailed description
Coronary artery disease (CAD) is the leading cause of death and morbidity in type 2 diabetes mellitus (T2DM) and diabetics holds the same risk for death or myocardial infarction (MI) as patients with a prior (MI) without diabetes. In addition to macrovascular complications, and traditional cardiac risk factors, T2DM is burdened by microvascular dysfunction affecting several organs. The dynamics between microvascular dysfunction, known cardiac risk factors and coronary atherosclerosis in diabetic disease is not well characterized.
In the present study, a primary cohort of 300 type 2 diabetics and a subgroup of 50-100 type 1 diabetics will be examined with CCTA at baseline and after one year. In addition, CAD in diabetes will be compared to a historical cohort of patients with acute myocardial infarction (AMI).
All study participant will undergo the following examinations at baseline:
- CCTA
- CAC-score
- Transthoracic echocardiography
- 12-lead ECG
- Blood pressure and pulse frequency
- Height, weight, waist to hip-ratio
- Blood samples and urin samples
- Medical history
After 12 months all of the above examinations will be repeated.
- Conditions
- Type2 Diabetes, Atherosclerosis, Plaque, Atherosclerotic, Plaque Vulnerability, Diabetes Complications, Microalbuminuria
- Medical subject headings
- Atherosclerosis, Plaque, Atherosclerotic, Diabetes Complications
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 |
|---|---|---|
| Type 2 diabetes | This group will consist of 300 patients with type 2 diabetes mellitus without symptoms or known coronary heart disease. The group will be followed for one year and CCTA will be performed at baseline and after one year. | |
| Type 1 diabetes | This group will consist of 50-100 patients with type 1 diabetes mellitus without symptoms or known coronary heart disease. The group will be followed for one year. CCTA will be performed at baseline and after one year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plaque burden stratified by diabetic complications.
Changes in plaque burden (percentage) during 12 months in diabetics with or without diabetic complications.
Measured: Baseline,12 months.
Changes in plaque burden stratified by cardiovascular risk factors
Changes in plaque burden during 12 months stratified by cardiovascular risk factors (hypertension,hypercholersterolemia, smoking, overweight/obesity)
Measured: Baseline, 12 months
Changes in plaque morphology stratified by diabetic complications
Changes in plaque morphology (PR, LAP, NRS, SC) during 12 months in diabetics either with or without diabetic complications.
Measured: Baseline, 12 months
Changes in plaque morphology stratified by cardiovascular risk factors.
Changes in plaque burden during 12-months stratified by cardiovascular risk factors
Measured: Baseline,12 months
Secondary outcomes (5)
Changes in plaque burden in diabetes compared to AMI-patients without diabetes.
A comparison of plaque burden (percentage) in diabetes and a historical cohort of AMI-patients.
Measured: Baseline and 12 months
Changes in plaque morphology in diabetes compared to AMI-patients without diabetes.
A comparison of plaque morphology in diabetes and a historical cohort of AMI-patients.
Measured: Baseline,12-months
Changes in plaque burden during 12 months in relation to HbA1c and cholesterol levels.
Changes in plaque burden during 12 months stratified by historical levels of cholesterol and HbA1c levels recorded from onset of diabetes to present.
Measured: Baseline,12-months
Changes in plaque morphology during 12 months in relation to HbA1c and cholesterol levels.
Changes in plaque morphology during 12 months stratified by historical levels of cholesterol and HbA1c levels recorded once a year from onset of diabetes to present.
Measured: Baseline,12-months
Impact of asymtomatic CAD in diabetes on future events.
Long term follow-up to evaluate the impact of asymptomatic CAD (plaque burden and morphology) in diabetes on death, coronary heart attack, hospitalization due to unstable angina, heart failure and ischemic stroke.
Clinical outcomes will be recorded from journal records and analyzed after 5-7 years.
Measured: 5-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startMar 2016
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (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 Type2 DiabetesStudies 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Svendborg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurits Heinsen, Svendborg Hospital
- Investigators
- Kenneth Egstrup, Prof. DMSci, Study director, Head of Reseach, Cardiovascular Research Unit, OUH Svendborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016910
- Sponsor's protocol ID
- CD20150029
- Acronym
- CARPEDIEM
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2017
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Heinsen LJ, Pararajasingam G, Andersen TR, Auscher S, Sheta HM, Precht H, Lambrechtsen J, Egstrup K. High-risk coronary artery plaque in asymptomatic patients with type 2 diabetes: clinical risk factors and coronary artery calcium score. Cardiovasc Diabetol. 2021 Aug 9;20(1):164. doi: 10.1186/s12933-021-01350-2.
PubMed 34372839
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Plaque Burden in Type 2 Diabetes Mellitus. Changes Over Time, Relation to Risk Profile, and Comparison to Acute Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT03016910
- Acronym / sponsor ID
- CARPEDIEM / CD20150029
- Conditions
- Type2 Diabetes, Atherosclerosis, Plaque, Atherosclerotic, Plaque Vulnerability, Diabetes Complications, Microalbuminuria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Svendborg HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- 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.
Unstable plaque, the primary cause of myocardial infarction, is characterized by distinct a morphology including positive remodeling (PR), low attenuated plaque (LAP), napkin ring sign (NRS), and spotty calcifications (SC) The purpose of the present study is to investigate the influence of microvascular dysfunction and additional risk factors on plaque morphology and plaque burden in patients with diabetes mellitus.
Detailed description
Coronary artery disease (CAD) is the leading cause of death and morbidity in type 2 diabetes mellitus (T2DM) and diabetics holds the same risk for death or myocardial infarction (MI) as patients with a prior (MI) without diabetes. In addition to macrovascular complications, and traditional cardiac risk factors, T2DM is burdened by microvascular dysfunction affecting several organs. The dynamics between microvascular dysfunction, known cardiac risk factors and coronary atherosclerosis in diabetic disease is not well characterized.
In the present study, a primary cohort of 300 type 2 diabetics and a subgroup of 50-100 type 1 diabetics will be examined with CCTA at baseline and after one year. In addition, CAD in diabetes will be compared to a historical cohort of patients with acute myocardial infarction (AMI).
All study participant will undergo the following examinations at baseline:
- CCTA
- CAC-score
- Transthoracic echocardiography
- 12-lead ECG
- Blood pressure and pulse frequency
- Height, weight, waist to hip-ratio
- Blood samples and urin samples
- Medical history
After 12 months all of the above examinations will be repeated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | – | –This group will consist of 300 patients with type 2 diabetes mellitus without symptoms or known coronary heart disease. The group will be followed for one year and CCTA will be performed at baseline and after one year. |
| Type 1 diabetes | – | –This group will consist of 50-100 patients with type 1 diabetes mellitus without symptoms or known coronary heart disease. The group will be followed for one year. CCTA will be performed at baseline and after one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 1 or 2 diabetes mellitus without history of CAD or relevant symptoms (angina). Patients are recruited at the out-patient clinic at Svendborg Hospital.
Key inclusion criteria (3 listed)
- Age > 18 years
- Type 1 or 2 diabetes mellitus
- Ability to provide informed conscent
Key exclusion criteria (7 listed)
- History of CAD
- Symtoms of CAD (angina)
- Any tachyarrhythmias making CCTA impossible
- Glumerular filtration rate (GFR)< 45 ml/min
- Allergy to iodine contrast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in plaque burden stratified by diabetic complications.
Time frame: Baseline,12 months.
Changes in plaque burden (percentage) during 12 months in diabetics with or without diabetic complications.
Changes in plaque burden stratified by cardiovascular risk factors
Time frame: Baseline, 12 months
Changes in plaque burden during 12 months stratified by cardiovascular risk factors (hypertension,hypercholersterolemia, smoking, overweight/obesity)
Changes in plaque morphology stratified by diabetic complications
Time frame: Baseline, 12 months
Changes in plaque morphology (PR, LAP, NRS, SC) during 12 months in diabetics either with or without diabetic complications.
Changes in plaque morphology stratified by cardiovascular risk factors.
Time frame: Baseline,12 months
Changes in plaque burden during 12-months stratified by cardiovascular risk factors
5 secondary outcomes
Changes in plaque burden in diabetes compared to AMI-patients without diabetes.
Time frame: Baseline and 12 months
Changes in plaque morphology in diabetes compared to AMI-patients without diabetes.
Time frame: Baseline,12-months
Changes in plaque burden during 12 months in relation to HbA1c and cholesterol levels.
Time frame: Baseline,12-months
Changes in plaque morphology during 12 months in relation to HbA1c and cholesterol levels.
Time frame: Baseline,12-months
Impact of asymtomatic CAD in diabetes on future events.
Time frame: 5-7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Derived from this study: PubMed 34372839Heinsen LJ, Pararajasingam G, Andersen TR, Auscher S, Sheta HM, Precht H, Lambrechtsen J, Egstrup K. High-risk coronary artery plaque in asymptomatic patients with type 2 diabetes: clinical risk factors and coronary artery calcium score. Cardiovasc Diabetol. 2021 Aug 9;20(1):164. doi: 10.1186/s12933-021-01350-2.
- Individual participant dataSharing planned: No
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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.
Kenneth Egstrup, Prof. DMSci study director
Head of Reseach, Cardiovascular Research Unit, OUH Svendborg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes and Atherosclerosis, run by Svendborg Hospital at 1 site in Denmark.
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 7 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 11 Jan 2017. 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 Denmark. 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.
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 Laurits J Heinsen, MD (+4563202429, lauritsheinsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in plaque burden stratified by diabetic complications. (time frame: Baseline,12 months.). The study lists 4 primary outcomes in all. 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 NCT03016910, 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 11 Jan 2017.