Status:
RECRUITING
COMPression of Left Main coRonary artEry in patientS With Pulmonary Arterial Hypertension aSymptomatIc fOr aNgina
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The prevalence of critical ab extrinsic compression of left main coronary artery (LMCA) is very high in patients with pulmonary arterial hypertension (PAH) symptomatic for angina (up to 40% according ...
Eligibility Criteria
Inclusion
- Patients with PAH (group 1 of World Health Organization pulmonary hypertension classification) who have undergone at least one pulmonary CT angiography with a PA trunk diameter ≥ 4 cm
- Age ≥18 years
- Asymptomaticity for angina pectoris or anginal equivalent
Exclusion
- Severe chronic kidney disease \[Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated glomerular filtration rate \<30 ml/min) or need for dialysis
- Major allergy to iodinated contrast agent
- Intolerance or allergy to acetylsalicylic acid or clopidogrel
- History of stroke or transient ischemic attack in the last 6 months or a history of intracranial haemorrhage
- Known cerebral arteriovenous malformation or aneurysm
- Known moderate or severe hepatic insufficiency (Child Pugh B or C)
- Thrombocytopenia (\<100.000/μL) or anemia (hemoglobin \<10 g/dL)
- Active bleeding or factors which, in the investigator's judgment, significantly increase the risk of bleeding
- Major surgery in the past 30 days
- Cancer in the active phase
- Pregnancy or breastfeeding
- Patient prognosis \<1 year in the opinion of the investigator
- Any condition that increases the risk of non-compliance or of being lost to follow-up
- Patients who have already undergone a LMCA angioplasty
- Failure to obtain informed consent
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05413109
Start Date
May 15 2022
End Date
May 15 2026
Last Update
May 10 2024
Active Locations (1)
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1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138