Actively Recruiting
COMPression of Left Main coRonary artEry in patientS With Pulmonary Arterial Hypertension aSymptomatIc fOr aNgina
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-05-10
150
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
COMPression of Left Main coRonary artEry in patientS With Pulmonary Arterial Hypertension aSymptomatIc fOr aNgina
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 63 4 cm
- Age 63 18 years
- Asymptomatic for angina pectoris or anginal equivalent
You will not qualify if you...
- Severe chronic kidney disease (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/bcL) 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
F
Fabio Dardi, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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