Coronary StenosisEURECASNCT05471687
Evaluation of the Functional Impact of Coronary Stenoses in Diabetics by Spectral CT
A study testing dual-energy dual-layer spectral scanner and Stress protocol with adenosin during dual-energy dual-layer spectral scanner in people with Coronary Stenosis and Diabetic, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The optimal screening methods for coronary insufficiency, a frequent and pejorative complication in diabetics, are subject to debate, particularly in situations of silent myocardial ischemia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Stenosis, Diabetic
- What is being tested?
- dual-energy dual-layer spectral scanner and Stress protocol with adenosin during dual-energy dual-layer spectral scanner
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 1 Mar 2025
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged man ≥50 years old or woman aged ≥55 years old, (age difference justified for established menopause which increases the CV risk and to avoid the risk of CT scan during pregnancy)
- Diabetic (type 1 or type 2 or type 3):
- Asymptomatic, falling within the scope of screening for silent myocardial ischemia and having a CAC > 300 AU or
- Symptomatic on the coronary level, within the framework of the evaluation of symptomatic coronary insufficiency with positive myocardial scintigraphy.
- Patient having agreed to participate in the study and signed a written informed consent
- Patient affiliated to a social security scheme or similar
Who cannot join
- Drug intolerance (adenosine, and/or contrast product used (Iomeron))
- Related to iodine injection:
- History of major immediate or delayed skin reaction + hypersensitivity to the active substance or to any of the excipients
- Renal failure with GFR < 45 ml/min -
- Known autonomic goiter with risk of thyrotoxicosis
- No suspension of the biguanide the same day of the examination (and resumed 48 hours later)
Show all 28Show fewer
- Linked to the injection of adenosine and regadenoson (Cf SPC Adenoscan combination with dipyridamole)
- 2nd or 3rd degree BAV not fitted, sinus dysfunction not fitted,
- Long QT syndrome,
- Decompensated heart failure,
- Unstable angina / Acute coronary syndrome / ATCD IDM less than a year old
- BP > 1800 mmHg < 100 mmHg
- Known stenosis of the common trunk (left),
- Tight heart valve stenosis.
- Uncorrected hypovolemia,
- Chronic obstructive pulmonary disease with clinical bronchospasm (e.g. bronchial asthma)
- Comitiality
- No suspension of dipyridamole (during the 48 hours before the examination)
- Severe hypotension
- Consumption of coffee, tobacco, tea, cola, banana, chocolate consumed before the examination (usual instructions in the event of myocardial stress protocol by adenosine agonist during the scintigraphy)
- Contraindication to adenosine: severe hypotension
- Related to scanner performance
- patient unable to maintain apnea.
- Calcium score > 500 on the common trunk
- Temporary suspension of bradycardia or anti-anginal on the day of the examination (beta blocker, calcium channel blocker) not carried out.
- Related to the patient's context
- Person unable to express their consent.
- Patient under guardianship, curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon
Bron, 69500
Philippe MOULIN, Pr, 04 72 68 13 04, philippe.moulin@chu-lyon.fr
Philippe DOUEK, Pr, philippe.douek@creatis.insa-lyon.fr
About this study
The optimal screening methods for coronary insufficiency, a frequent and pejorative complication in diabetics, are subject to debate, particularly in situations of silent myocardial ischemia. The contemporary strategy consists of pre-selecting asymptomatic patients at very high cardiovascular (CV) risk by performing a coronary calcium score. If this is found to be high >300 AU (Agatston units), the patient is suspected of being at high risk of silent myocardial ischemia (SMI), and the assessment is completed to exclude the presence of coronary artery disease likely to benefit from revascularization.
The complementary evaluation consists in evaluating the myocardial perfusion to judge the perfusion repercussions. The most common examination to date is myocardial scintigraphy, because stress tests are too frequently submaximal in diabetics. However, the reproducibility of scintigraphy is controversial and their sensitivity and specificity are debated in this indication.
Read more
This problem is similar in stable symptomatic coronary diabetic patients for whom an indication for functional examinations is justified.
The double-energy double-layer spectral scanner (SDEDC) could now become a relevant tool in this field, since it can combine not only anatomical data (identification of coronary stenosis) but also functional data (myocardial perfusion) during a stress protocol. thanks to the spectral images which make it possible to measure the tissue concentration of intramyocardial iodine downstream of the considered stenosis.
- Conditions
- Coronary Stenosis, Diabetic
- Being tested
- dual-energy dual-layer spectral scanner, Stress protocol with adenosin during dual-energy dual-layer spectral scanner
- Keywords
- coronary stenosis, diabetics, coronary calcium score, spectral CT
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual-energy dual-layer spectral scannerDevice
Realization of dual-energy dual-layer spectral scanner with stress protocol
Stress protocol with adenosin during dual-energy dual-layer spectral scannerDrug
Injection of intraveinous adenosin dose 0.78 mg/kg during dual-energy dual-layer spectral scanner
| Study group | Role | What they receive |
|---|---|---|
| Patients with CAC ≥ 300 three years ago | Experimental | Patients with CAC ≥ 300 three years ago with the need for repeat screening. Adult asymptomatic diabetic patients whose risk of ischemic complications is considered major in primary prevention due to a calcium score >300 AU and requiring iterative screening for IMS recommended every 3 at 5 years. Receives: Device: dual-energy dual-layer spectral scanner; Drug: Stress protocol with adenosin during dual-energy dual-layer spectral scanner |
| Patients with CAC between 200-299 three years ago | Experimental | Patients with CAC between 200 and 299 three years ago, with the need for a reassessment of their cardiovascular risk.
Adult asymptomatic diabetic patients whose risk of ischemic complications is considered major in primary prevention due to a calcium score that has become pathological > 300 AU during the reassessment of their cardiovascular risk. Receives: Device: dual-energy dual-layer spectral scanner; Drug: Stress protocol with adenosin during dual-energy dual-layer spectral scanner |
| Patients with a recent positive scintigraphy (< three months) | Experimental | Patients with a recent positive scintigraphy (< three months) requiring coronary angiography Stable symptomatic diabetic adult patients, suspected of coronary insufficiency in whom the assessment included a positive scintigraphy with indication of coronary angiography in the perspective of revascularization. Receives: Device: dual-energy dual-layer spectral scanner; Drug: Stress protocol with adenosin during dual-energy dual-layer spectral scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of tight coronary stenoses justifying coronary angiography
An anomaly considered significant corresponds to:
- the presence of coronary stenosis >50% with significant hypoperfusion or stenosis > 75% by spectral CT (SDEDC)
- of a significant hypoperfusion on myocardial scintigraphy (SPECT)
Reading Committee: Creation of a blind review committee for myocardial SPECT scans and the SDEDC spectral scanner, without knowledge of the coronary angiography data or the other perfusion examination for statistical comparison.
Measured: Measured at day 0
Secondary outcomes (4)
Identification of tight coronary stenoses justifying a coronary angiography including a measurement of the Fractional Flow Reserve (FFR)
An anomaly considered significant corresponds to:
- the presence of coronary stenosis >50% with significant hypoperfusion or stenosis > 75% by spectral CT (SDEDC)
- of a significant hypoperfusion on myocardial scintigraphy (SPECT)
Reading Committee: Creation of a blind review committee for myocardial SPECT scans and the SDEDC spectral scanner, without knowledge of the coronary angiography data or the other perfusion examination for statistical comparison.
Measured: Measured at day 0
Sensitivity and specificity of the study
Sensitivity and specificity of the study of the perfusion at rest during the SDEDC: 1 to 1 comparison of the data of the SDEC at rest (stenosis and perfusion) with the FFR; with the sensitivities and specificities of SDEDC perfusion to stress; with SPECT scintigraphy under stress.
Reading Committee: Creation of a blind review committee for myocardial SPECT scans and the SDEDC spectral scanner, without knowledge of the coronary angiography data or the other perfusion examination for statistical comparison.
Measured: Measured at day 0
Proportion of mismatches in diabetics and their predisposing factors
Proportion of mismatches in diabetics and their predisposing factors by identifying tissue perfusion defects (SPECT or SDEDC positive) in patients with a coronary network without angiographically tight stenosis (negative coronarography).
Reading Committee: Creation of a blind review committee for myocardial SPECT scans and the SDEDC spectral scanner, without knowledge of the coronary angiography data or the other perfusion examination for statistical comparison.
Measured: Measured at day 0
Collection of the subjective assessment of the 2 examinations (SDEDC and myocardial scintigraphy)
Collection of the subjective assessment of the 2 examinations (SDEDC and myocardial scintigraphy) by the patients using a satisfaction questionnaire by telephone call.
Measured: Measured at day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471687
- Sponsor's protocol ID
- 69HCL19_0931
- Acronym
- EURECAS
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Functional Impact of Coronary Stenoses in Diabetics by Spectral CT
- ClinicalTrials.gov ID
- NCT05471687
- Acronym / sponsor ID
- EURECAS / 69HCL19_0931
- Conditions
- Coronary Stenosis, Diabetic
- Keywords
- coronary stenosis, diabetics, coronary calcium score, spectral CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 25 Jul 2022 (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 screening methods for coronary insufficiency, a frequent and pejorative complication in diabetics, are subject to debate, particularly in situations of silent myocardial ischemia. The contemporary strategy consists of pre-selecting asymptomatic patients at very high cardiovascular (CV) risk by performing a coronary calcium score. If this is found to be high >300 AU (Agatston units), the patient is suspected of being at high risk of silent myocardial ischemia (SMI), and the assessment is completed to exclude the presence of coronary artery disease likely to benefit from revascularization.
The complementary evaluation consists in evaluating the myocardial perfusion to judge the perfusion repercussions. The most common examination to date is myocardial scintigraphy, because stress tests are too frequently submaximal in diabetics. However, the reproducibility of scintigraphy is controversial and their sensitivity and specificity are debated in this indication.
This problem is similar in stable symptomatic coronary diabetic patients for whom an indication for functional examinations is justified.
The double-energy double-layer spectral scanner (SDEDC) could now become a relevant tool in this field, since it can combine not only anatomical data (identification of coronary stenosis) but also functional data (myocardial perfusion) during a stress protocol. thanks to the spectral images which make it possible to measure the tissue concentration of intramyocardial iodine downstream of the considered stenosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with CAC ≥ 300 three years ago | Experimental | Device: dual-energy dual-layer spectral scanner, Drug: Stress protocol with adenosin during dual-energy dual-layer spectral scannerPatients with CAC ≥ 300 three years ago with the need for repeat screening. Adult asymptomatic diabetic patients whose risk of ischemic complications is considered major in primary prevention due to a calcium score >300 AU and requiring iterative screening for IMS recommended every 3 at 5 years. |
| Patients with CAC between 200-299 three years ago | Experimental | Device: dual-energy dual-layer spectral scanner, Drug: Stress protocol with adenosin during dual-energy dual-layer spectral scannerPatients with CAC between 200 and 299 three years ago, with the need for a reassessment of their cardiovascular risk. Adult asymptomatic diabetic patients whose risk of ischemic complications is considered major in primary prevention due to a calcium score that has become pathological > 300 AU during the reassessment of their cardiovascular risk. |
| Patients with a recent positive scintigraphy (< three months) | Experimental | Device: dual-energy dual-layer spectral scanner, Drug: Stress protocol with adenosin during dual-energy dual-layer spectral scannerPatients with a recent positive scintigraphy (< three months) requiring coronary angiography Stable symptomatic diabetic adult patients, suspected of coronary insufficiency in whom the assessment included a positive scintigraphy with indication of coronary angiography in the perspective of revascularization. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged man ≥50 years old or woman aged ≥55 years old, (age difference justified for established menopause which increases the CV risk and to avoid the risk of CT scan during pregnancy)
- Diabetic (type 1 or type 2 or type 3):
- Asymptomatic, falling within the scope of screening for silent myocardial ischemia and having a CAC > 300 AU or
- Symptomatic on the coronary level, within the framework of the evaluation of symptomatic coronary insufficiency with positive myocardial scintigraphy.
- Patient having agreed to participate in the study and signed a written informed consent
Key exclusion criteria (28 listed)
- Drug intolerance (adenosine, and/or contrast product used (Iomeron))
- History of major immediate or delayed skin reaction + hypersensitivity to the active substance or to any of the excipients
- Renal failure with GFR < 45 ml/min -
- Known autonomic goiter with risk of thyrotoxicosis
- No suspension of the biguanide the same day of the examination (and resumed 48 hours later)
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 |
|---|---|---|
| dual-energy dual-layer spectral scannerRealization of dual-energy dual-layer spectral scanner with stress protocol | Device | Patients with CAC between 200-299 three years ago, Patients with CAC ≥ 300 three years ago, Patients with a recent positive scintigraphy (< three months) |
| Stress protocol with adenosin during dual-energy dual-layer spectral scannerInjection of intraveinous adenosin dose 0.78 mg/kg during dual-energy dual-layer spectral scanner | Drug | Patients with CAC between 200-299 three years ago, Patients with CAC ≥ 300 three years ago, Patients with a recent positive scintigraphy (< three months) |
Primary outcome
Identification of tight coronary stenoses justifying coronary angiography
Time frame: Measured at day 0
An anomaly considered significant corresponds to: * the presence of coronary stenosis >50% with significant hypoperfusion or stenosis > 75% by spectral CT (SDEDC) * of a significant hypoperfusion on myocardial scintigraphy (SPECT) Reading Committee: Creation of a blind review committee for myocardial SPECT scans and the SDEDC spectral scanner, without knowledge of the coronary angiography data or the other perfusion examination for statistical comparison.
4 secondary outcomes
Identification of tight coronary stenoses justifying a coronary angiography including a measurement of the Fractional Flow Reserve (FFR)
Time frame: Measured at day 0
Sensitivity and specificity of the study
Time frame: Measured at day 0
Proportion of mismatches in diabetics and their predisposing factors
Time frame: Measured at day 0
Collection of the subjective assessment of the 2 examinations (SDEDC and myocardial scintigraphy)
Time frame: Measured at day 1 and 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual-energy dual-layer spectral scanner and Stress protocol with adenosin during dual-energy dual-layer spectral scanner in people with Coronary Stenosis and Diabetic, run by Hospices Civils de Lyon at 1 site in France.
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 28 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 25 Jul 2022. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of tight coronary stenoses justifying coronary angiography (time frame: Measured at day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2022.