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

July 20, 2022 updated by: Hospices Civils de Lyon

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with CAC ≥ 300 three years ago
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.
Device: dual-energy dual-layer spectral scanner
Realization of dual-energy dual-layer spectral scanner with stress protocol
Drug: Stress protocol with adenosin during dual-energy dual-layer spectral scanner
Injection of intraveinous adenosin dose 0.78 mg/kg during dual-energy dual-layer spectral scanner
EXPERIMENTAL: Patients with CAC between 200-299 three years ago

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.
Device: dual-energy dual-layer spectral scanner
Realization of dual-energy dual-layer spectral scanner with stress protocol
Drug: Stress protocol with adenosin during dual-energy dual-layer spectral scanner
Injection of intraveinous adenosin dose 0.78 mg/kg during dual-energy dual-layer spectral scanner
EXPERIMENTAL: Patients with a recent positive scintigraphy (< three months)
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.
Device: dual-energy dual-layer spectral scanner
Realization of dual-energy dual-layer spectral scanner with stress protocol
Drug: Stress protocol with adenosin during dual-energy dual-layer spectral scanner
Injection of intraveinous adenosin dose 0.78 mg/kg during dual-energy dual-layer spectral scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of tight coronary stenoses justifying a coronary angiography including a measurement of the Fractional Flow Reserve (FFR)
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.
Measured at day 0
Sensitivity and specificity of the study
Time Frame: Measured at day 0

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 at day 0
Proportion of mismatches in diabetics and their predisposing factors
Time Frame: Measured at day 0

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 at day 0
Collection of the subjective assessment of the 2 examinations (SDEDC and myocardial scintigraphy)
Time Frame: Measured at day 1 and 2
Collection of the subjective assessment of the 2 examinations (SDEDC and myocardial scintigraphy) by the patients using a satisfaction questionnaire by telephone call.
Measured at day 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2022

Primary Completion (ANTICIPATED)

September 1, 2024

Study Completion (ANTICIPATED)

March 1, 2025

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (ACTUAL)

July 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0931

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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