Trials / Recruiting
RecruitingNCT05413109
COMPression of Left Main coRonary artEry in patientS With Pulmonary Arterial Hypertension aSymptomatIc fOr aNgina
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Coronary 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. |
Timeline
- Start date
- 2022-05-15
- Primary completion
- 2025-05-15
- Completion
- 2026-05-15
- First posted
- 2022-06-09
- Last updated
- 2024-05-10
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05413109. Inclusion in this directory is not an endorsement.