Assessing coronary artery compression in patients with pulmonary arterial hypertension
COMPression of Left Main coRonary artEry in patientS With Pulmonary Arterial Hypertension aSymptomatIc fOr aNgina
This study is trying to see if people with pulmonary arterial hypertension and a larger pulmonary artery are at risk for compression of a key heart artery, even if they don’t have chest pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT05413109 on ClinicalTrials.gov |
What this trial studies
This study investigates the prevalence of left main coronary artery (LMCA) compression in patients with pulmonary arterial hypertension (PAH) who are asymptomatic for angina. It aims to identify patients with a pulmonary artery diameter of 4 cm or greater, as this is associated with a higher risk of LMCA compression. The methodology involves performing coronary CT angiography to evaluate the degree of compression and its potential implications for patient health. The study seeks to enhance understanding of coronary artery health in PAH patients, particularly those who do not exhibit typical symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with pulmonary arterial hypertension and a pulmonary artery trunk diameter of 4 cm or greater who are asymptomatic for angina.
Not a fit: Patients with severe chronic kidney disease, major allergies to contrast agents, or significant bleeding risks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and management strategies for patients with pulmonary arterial hypertension, potentially reducing the risk of sudden cardiac events.
How similar studies have performed: Preliminary data from similar studies suggest that assessing coronary artery compression in PAH patients may reveal significant health risks, indicating a potential for impactful findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Fabio Dardi, PhD, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna (Italy)
- Study coordinator: Fabio Dardi, PhD, MD
- Email: fabio.dardi@aosp.bo.it
- Phone: +39 0512144008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.