- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05159791
New Patient-specific Functional Assessment of the Anomalous Aortic Origin of Coronary Arteries. (NECESSARY)
Study Overview
Status
Conditions
Detailed Description
Anomalous Aortic Origin of Coronary Arteries (AAOCA) is a congenital condition where one or more coronary vessels originate from an ectopic site within the aorta, such as the opposite or wrong sinus of Valsalva. Its prevalence in the general population, has been estimated between 0.03% and 0.23% depending on the variant evaluated. The anomalous left or right coronary artery, besides its origin, may take 5 different general courses: interarterial, prepulmonic, subpulmonic, retroaortic or retrocardiac. Each of these forms may be subject to cause myocardial ischemia and subsequent sudden death during physical and sport activity.
In most cases, the disease is silent and does not show any symptoms before the sudden cardiac death event (SCD). Only a few AAOCA subjects report symptoms before SCD that usually occurs unexpectedly after a moderate or intense physical activity. It is extremely hard to study the causing factors in a clinical environment due to the stochastic nature of the myocardial ischemic event and the inability to reproduce the exact effort conditions.
Even when a complete assessment is performed, there is no clinical exam that can reproduce sustained exercise conditions responsible for triggering ischemia and SCD. Even if such an exam would exist and provide adequate results, the risk of SCD exceeds the benefits of having a correct diagnosis.
To overcome all the current diagnostic limitations the ideal diagnostic test has to investigate coronary blood supply, myocardial oxygen demand in relation to the physical activity (intensity and duration) required for triggering an ischemic event, without putting the subjects at risk. To date the only possible way to reproduce such conditions is a subject-specific virtual simulation of aortic root and coronary artery integrated with coronary blood flow simulation able to mimic pressure, flow, and oxygen demand characteristics similar to those of intense exercise, in relation to changes that anomalous coronary undergoes under such conditions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mauro Lo Rito, MD
- Phone Number: +39 0252774849
- Email: Mauro.lorito@grupposandonato.it
Study Locations
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-
MI
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San Donato Milanese, MI, Italy, 20097
- Recruiting
- IRCCS Policlinico San Donato
-
Contact:
- Mauro Lo Rito, MD
- Phone Number: +39 0252774849
- Email: Mauro.lorito@grupposandonato.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with a diagnosis of AAOCA of any age will undergo fluid dynamic simulation
- Patients with age > 14 with diagnosis of AAOCA will undergo to invasive coronary flow measurements
- Informed consent
Exclusion Criteria:
- A presence of major associated congenital heart anomalies
- Contraindication to the execution of the diagnostic examination requested such as age < 14 years for invasive coronary flow measurements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anomalous coronary blood flow
Subjects suspected to have AAOCA will be submitted to angiographic coronary CT imaging to confirm the diagnosis.
If the diagnosis of AAOCA will be confirmed, subjects will undergo to invasive coronary blood flow evaluation (intervention).
|
The coronary blood flow and its distribution between the anomalous and normal artery will be measured by invasive coronary catheterization.
Coronary artery flow will be calculated based on intravascular ultrasound (IVUS) and pressure difference measurements.
After the IVUS assessment, a pressure transducer (FFR/iFR probe) will be inserted in the coronary artery for pressure measurements.
The measurements will be done in the anomalous and normal coronary arteries in each patient to determine coronary flow distribution.
Patient's specific heart parameters will be retrieve from CT, MRI and other diagnostic tests and integrated in the simulation module.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of myocardial ischemia on simulation model
Time Frame: 3 years
|
Assess myocardial ischemia in the patient's specific model during simulated effort correlating coronary artery blood supply to myocardial oxygen demand.
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3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Invasive coronary flow distribution assessment
Time Frame: During clinical diagnostic evaluation, average 3 months after
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Evaluation of coronary blood flow (ml/min) in anomalous coronary artery and in normal coronary artery.
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During clinical diagnostic evaluation, average 3 months after
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Integration of different coronary artery imaging modality
Time Frame: During clinical diagnostic evaluation, average 6 months
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CT 3D reconstruction of aorta and coronary artery with aorta and coronary artery cross-sectional area (mm2); IVUS coronary artery reconstruction cross-sectional area (mm2); coronary blood flow quantification (ml/min)
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During clinical diagnostic evaluation, average 6 months
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Computational fluid dynamic simulation
Time Frame: 3 years
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Correlation between at rest estimated coronary blood flow (patient's specific FSI model) and the measured invasive coronary blood flow (FFR and derived measures).
|
3 years
|
In vitro effort fluid dynamic simulation
Time Frame: 3 years
|
FSI model effort will be simulated by increasing heart rate (bpm) and pressure (mmHg) that will determine changes in coronary artery cross-sectional area (mm2).
The outcome of the FSI effort simulation will be measured as changes in coronary artery blood flow (ml/min)
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mauro Lo Rito, MD, IRCCS Policlinico S. Donato
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Biomechanics
- Hemodynamics
- Simulation
- Fluid mechanics studies of circulation
- Fluid mechanics studies of microcirculation
- Fluid mechanics studies of transport systems
- Computational fluid dynamics
- Mathematical modeling
- Ventricular remodeling
- Tissue and organ mechanics
- Mechanics of injury
- Coronary congenital anomalies
- Coronary blood flow assessment
- Personalized functional risk assessment
- Computaional fluid dynamics
- Structural finite element analysis
- Integration of multimodal imaging
Additional Relevant MeSH Terms
Other Study ID Numbers
- GR-2019-12369116
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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