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Evaluation of the Functional Impact of Coronary Stenoses in Diabetics by Spectral CT (EURECAS)

Primary Purpose

Coronary Stenosis, Diabetic

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dual-energy dual-layer spectral scanner
Stress protocol with adenosin during dual-energy dual-layer spectral scanner
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Stenosis focused on measuring coronary stenosis, diabetics, coronary calcium score, spectral CT

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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)

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

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patients with CAC ≥ 300 three years ago

Patients with CAC between 200-299 three years ago

Patients with a recent positive scintigraphy (< three months)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
June 30, 2022
Last Updated
July 20, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05471687
Brief Title
Evaluation of the Functional Impact of Coronary Stenoses in Diabetics by Spectral CT
Acronym
EURECAS
Official Title
Evaluation of the Functional Impact of Coronary Stenoses in Diabetics by Spectral CT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis, Diabetic
Keywords
coronary stenosis, diabetics, coronary calcium score, spectral CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with CAC ≥ 300 three years ago
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients with CAC between 200-299 three years ago
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients with a recent positive scintigraphy (< three months)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
dual-energy dual-layer spectral scanner
Intervention Description
Realization of dual-energy dual-layer spectral scanner with stress protocol
Intervention Type
Drug
Intervention Name(s)
Stress protocol with adenosin during dual-energy dual-layer spectral scanner
Intervention Description
Injection of intraveinous adenosin dose 0.78 mg/kg during dual-energy dual-layer spectral scanner
Primary Outcome Measure Information:
Title
Identification of tight coronary stenoses justifying coronary angiography
Description
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.
Time Frame
Measured at day 0
Secondary Outcome Measure Information:
Title
Identification of tight coronary stenoses justifying a coronary angiography including a measurement of the Fractional Flow Reserve (FFR)
Description
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.
Time Frame
Measured at day 0
Title
Sensitivity and specificity of the study
Description
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.
Time Frame
Measured at day 0
Title
Proportion of mismatches in diabetics and their predisposing factors
Description
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.
Time Frame
Measured at day 0
Title
Collection of the subjective assessment of the 2 examinations (SDEDC and myocardial scintigraphy)
Description
Collection of the subjective assessment of the 2 examinations (SDEDC and myocardial scintigraphy) by the patients using a satisfaction questionnaire by telephone call.
Time Frame
Measured at day 1 and 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe MOULIN, Pr
Phone
04 72 68 13 04
Email
philippe.moulin@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Philippe DOUEK, Pr
Email
philippe.douek@creatis.insa-lyon.fr
First Name & Middle Initial & Last Name & Degree
Philippe MOULIN, Pr
First Name & Middle Initial & Last Name & Degree
Philippe DOUEK, Pr

12. IPD Sharing Statement

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Evaluation of the Functional Impact of Coronary Stenoses in Diabetics by Spectral CT

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