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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Coronary CT angiography
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • Obtaining informed consent

Exclusion Criteria:

  • Patients with angina pectoris
  • Severe chronic kidney disease [Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated glomerular filtration rate <30 ml/min) or need for dialysis
  • 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
  • Oral anticoagulant therapy which cannot be suspended for the duration of the study
  • 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

Sites / Locations

  • IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coronary-CT

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of extrinsic compression of the LMCA by radiological pattern
To evaluate the incidence of extrinsic compression of LMCA in the different possible radiological patterns described by coronary CT angiography (compression, dislocation, contiguity)
Safety of LMCA angioplasty
To evaluate the safety of the LMCA angioplasty in patients with LMCA critical ab extrinsic compression by evaluating the incidence of in-hospital complications [death, myocardial infarction, transient ischemic attack (TIA) or stroke, re-angioplasty, or acute stent thrombosis, vascular complications, acute kidney injury] and at 1 year [death, myocardial infarction, TIA or stroke, restenosis, stent thrombosis and bleeding whose severity will be assessed according to the Bleeding Academic Research Consortium (BARC) classification]
Six minute walking test (6MWT)
In patients who will undergo LMCA angioplasty for LMCA critical ab extrinsic compression the change from baseline in the six-minute walk test (6MWT) after the procedure will be evaluated

Full Information

First Posted
June 7, 2022
Last Updated
June 7, 2022
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT05413109
Brief Title
COMPression of Left Main coRonary artEry in patientS With Pulmonary Arterial Hypertension aSymptomatIc fOr aNgina
Acronym
COMPRESSION
Official Title
COMPression of Left Main coRonary artEry in patientS With Pulmonary Arterial Hypertension aSymptomatIc fOr aNgina
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
May 15, 2025 (Anticipated)
Study Completion Date
May 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coronary-CT
Arm Type
Experimental
Arm Description
Patients with PAH, asymptomatic for angina, with a PA trunk diameter ≥ 4 cm that undergo a coronary-CT scan examination
Intervention Type
Radiation
Intervention Name(s)
Coronary CT angiography
Intervention Description
A coronary CT angiography will be used to study the relationship between the PA and the LMCA and 4 radiological patterns will be considered: "Normal": minimum distance between the two vessels> 1 mm; "Proximity": distance between the two vessels ≤1 mm without displacement or stenosis of the LMCA; "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); "Compression": stenosis of the LMCA ≥50% due to extrinsic compression by the PA.
Primary Outcome Measure Information:
Title
Incidence of extrinsic compression of the LMCA
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Incidence of extrinsic compression of the LMCA by radiological pattern
Description
To evaluate the incidence of extrinsic compression of LMCA in the different possible radiological patterns described by coronary CT angiography (compression, dislocation, contiguity)
Time Frame
Baseline
Title
Safety of LMCA angioplasty
Description
To evaluate the safety of the LMCA angioplasty in patients with LMCA critical ab extrinsic compression by evaluating the incidence of in-hospital complications [death, myocardial infarction, transient ischemic attack (TIA) or stroke, re-angioplasty, or acute stent thrombosis, vascular complications, acute kidney injury] and at 1 year [death, myocardial infarction, TIA or stroke, restenosis, stent thrombosis and bleeding whose severity will be assessed according to the Bleeding Academic Research Consortium (BARC) classification]
Time Frame
Baseline, 1 year
Title
Six minute walking test (6MWT)
Description
In patients who will undergo LMCA angioplasty for LMCA critical ab extrinsic compression the change from baseline in the six-minute walk test (6MWT) after the procedure will be evaluated
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 Obtaining informed consent Exclusion Criteria: Patients with angina pectoris Severe chronic kidney disease [Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated glomerular filtration rate <30 ml/min) or need for dialysis 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 Oral anticoagulant therapy which cannot be suspended for the duration of the study 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio Dardi, PhD, MD
Phone
+39 0512144008
Email
fabio.dardi@aosp.bo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Dardi, PhD, MD
Organizational Affiliation
IRCCS Azienda Ospedaliero-Universitaria di Bologna (Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Dardi, MD, PhD
Phone
+390512144008
Email
fabio.dardi@aosp.bo.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28595696
Citation
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.
Results Reference
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PubMed Identifier
29096819
Citation
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.
Results Reference
background
PubMed Identifier
30732740
Citation
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.
Results Reference
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COMPression of Left Main coRonary artEry in patientS With Pulmonary Arterial Hypertension aSymptomatIc fOr aNgina

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