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

NCT05413109 | Recruiting DMC

• 1 other identifier: COMPRESSION
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Incidence of extrinsic compression of the LMCA

  To evaluate the incidence of extrinsic compression of the LMCA in patients with PAH and a PA diameter of at least 4 cm, asymptomatic for angina pectoris, subjected to a screening test by coronary CT angiography

  Baseline

Secondary Outcomes (3)

• Incidence of extrinsic compression of the LMCA by radiological pattern

  Baseline

• Number of participants undergoing LMCA angioplasty with in-hospital complications

  Baseline, 1 year

• Six minute walking test (6MWT)

  Baseline, 6 months

Study Arms (1)

Coronary-CT

EXPERIMENTAL

Patients with PAH, asymptomatic for angina, with a PA trunk diameter ≥ 4 cm that undergo a coronary-CT scan examination

Radiation: Coronary CT angiography

Interventions

Coronary CT angiography RADIATION

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.

Coronary-CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Related Publications (3)

• Galie N, Saia F, Palazzini M, Manes A, Russo V, Bacchi Reggiani ML, Dall'Ara G, Monti E, Dardi F, Albini A, Rinaldi A, Gotti E, Taglieri N, Marrozzini C, Lovato L, Zompatori M, Marzocchi A. Left Main Coronary Artery Compression in Patients With Pulmonary Arterial Hypertension and Angina. J Am Coll Cardiol. 2017 Jun 13;69(23):2808-2817. doi: 10.1016/j.jacc.2017.03.597.

  PMID: 28595696 BACKGROUND

• Saia F, Palazzini M, Taglieri N, Manes A, Dardi F, Rinaldi A, Gotti E, Galie N. Reply: Left Main Extrinsic Compression in Pulmonary Arterial Hypertension: From Identification to Percutaneous Coronary Intervention Optimization. J Am Coll Cardiol. 2017 Nov 7;70(19):2460-2461. doi: 10.1016/j.jacc.2017.08.067. No abstract available.

  PMID: 29096819 BACKGROUND

• Saia F, Dall'Ara G, Marzocchi A, Dardi F, Palazzini M, Manes A, Taglieri N, Marrozzini C, Rinaldi A, Galie N. Left Main Coronary Artery Extrinsic Compression in Patients With Pulmonary Arterial Hypertension: Technical Insights and Long-Term Clinical Outcomes After Stenting. JACC Cardiovasc Interv. 2019 Feb 11;12(3):319-321. doi: 10.1016/j.jcin.2018.08.002. No abstract available.

  PMID: 30732740 BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fabio Dardi, PhD, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna (Italy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Dardi, PhD, MD

CONTACT

+39 0512144008; fabio.dardi@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: May 15, 2022
• Primary Completion: May 15, 2025
• Study Completion (Estimated): May 15, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)