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

NCT05471687 | Unknown

• 1 other identifier: 69HCL19_0931
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Stenosis; Diabetic

Keywords

coronary stenosis; diabetics; coronary calcium score; spectral CT

Outcome Measures

Primary Outcomes (1)

• 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 at day 0

Secondary Outcomes (4)

• Identification of tight coronary stenoses justifying a coronary angiography including a measurement of the Fractional Flow Reserve (FFR)

  Measured at day 0

• Sensitivity and specificity of the study

  Measured at day 0

• Proportion of mismatches in diabetics and their predisposing factors

  Measured at day 0

• Collection of the subjective assessment of the 2 examinations (SDEDC and myocardial scintigraphy)

  Measured at day 1 and 2

Study Arms (3)

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.

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.

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.

Device: dual-energy dual-layer spectral scanner; Drug: Stress protocol with adenosin during dual-energy dual-layer spectral scanner

Interventions

dual-energy dual-layer spectral scanner DEVICE

Realization of dual-energy dual-layer spectral scanner with stress protocol

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 scanner DRUG

Injection of intraveinous adenosin dose 0.78 mg/kg during dual-energy dual-layer spectral scanner

Patients with CAC between 200-299 three years ago; Patients with CAC ≥ 300 three years ago; Patients with a recent positive scintigraphy (< three months)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• nd 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,

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 25, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

FR (1)