Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT02472002
Eligibility Criteria:
Inclusion criteria :
1. Cardiac transplant patient whatever is his initial pathology
2. Coronary vasculopathy grade 3 (CAV3) defined by:
Stenosis \> 50% of common-core (CT) or stenosis \>70% of at least 2 or 3 main coronary arteries or stenosis \> 70% on secondary branches of 3 territories.
Coronary vasculopathy grade 1 or 2 (CAV 1 or 2) associated with FELV (FEVG) dysfunction \<45% or abnormality of completion of restrictive type.
3. Defect of drip on at least 2 segments/17 in stress MRI.
4. Fraction of ejection LV\<50 measured on ultrasound examination or confusion of diastolic function defined by a restrictive mitral steam (E/A \> 2 or E/A between 1 and 2 and deceleration time E \< 150 ms) or left ventricular diastolic pressure measured during coronarography \>16mg Hg .
5. Without sign of acute rejection at the time of inclusion.
6. Under an optimal medical treatment
7. Patient who have given his enlightened and signed consent
Exclusion criteria :
1. Patients \<18 ou \>80 years
2. Acute coronary syndrome or revascularisation in the 3 last months
3. Acute cardiac rejection in the 3 last months
4. Atrial fibrillation
5. Claustrophobia or contraindication to MRI (ex:pace-maker), to contrast injection or adenosine.
6. Presence of a thrombus in the left cavities detected by ultra-sound examination or MRI realized before the injection..
7. Pregnant or breast-feeding woman
8. Woman old enough to reproduction without effective means of contraception during its participation in the study
9. Patient benefiting from a legal protective measure
10. HIV positive
11. Not membership in a national save insurance (beneficiary or legal successor)
12. Patients undergoing others biomedical research
13. Patient not understanding the procedure bound to the protocol
14. Bad adhesion to the protocol suspected by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02472002
Study Brief:
Protocol Section:
NCT02472002