RecruitingNot ApplicableNCT05413109

COMPression of Left Main coRonary artEry in patientS With Pulmonary Arterial Hypertension aSymptomatIc fOr aNgina

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

150 participants

Start Date

May 15, 2022

Study Type

INTERVENTIONAL

Conditions

Pulmonary Arterial Hypertension

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 to a recent study of 121 patients with PAH). The element that most of all correlates with the degree of coronary stenosis is the diameter of the pulmonary artery (PA). In particular, a diameter ≥ 40 mm has a sensitivity of 83% and a specificity of 70% in patients with angina. Critical stenosis of LMCA is a risk factor for sudden death and in these condition percutaneous coronary angioplasty with stent implantation has proven to be a safe and effective long-term procedure. Preliminary data from a retrospective analysis of the registry of patients with PAH in Bologna (ARCA registry, 109/2016/U/Oss) highlights that even in PAH patients asymptomatic for angina, compression of LMCA can occur in up to 13% of patients and the main predictive parameter of compression was found to be a diameter ≥ 42 mm (with a sensitivity of 87% and a specificity of 77%). Performing a screening test by coronary-CT scan in all subjects suffering of PAH with a PA diameter ≥ 40 mm even if asymptomatic for angina could therefore help to identify patients with PAH at increased risk for sudden death at an early stage.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria15

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

Interventions

RADIATIONCoronary CT angiography

A coronary CT angiography will be used to study the relationship between the PA and the LMCA and 4 radiological patterns will be considered: 1. "Normal": minimum distance between the two vessels\> 1 mm; 2. "Proximity": distance between the two vessels ≤1 mm without displacement or stenosis of the LMCA; 3. "Dislocation": dislocation of the LMCA by the main branch of the PA with a take-off angle \<60 ° (the take-off angle is defined by the angle formed by the perpendicular to the aortic valve ring and the longitudinal axis of the LMCA); 4. "Compression": stenosis of the LMCA ≥50% due to extrinsic compression by the PA.