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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Enrolling

Conditions

Pulmonary Arterial Hypertension

Treatments

Radiation: Coronary CT angiography

Study type

Interventional

Funder types

Other

Identifiers

NCT05413109

COMPRESSION

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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