Association of Plasma N-terminal Pro-Brain Natriuretic Peptide Levels With the Burden of Coronary Artery Disease

NCT07013344 | Recruiting

• 1 other identifier: BNP-CAD-HSR-2025
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 2

Brief Summary

This study aim to investigate the association between plasma NT-proBNP levels and the presence, extent and severity of stenosis in patients with suspected coronary artery disease.

Conditions

Chronic Coronary Syndrome; Chronic Coronary Total Occlusion; Coronary Arterial Disease (CAD); Stable Chronic Angina; NT-pro-BNP

Keywords

NT-pro-BNP; Coronary Arterial Disease (CAD); Chronic Coronary Syndrome (CCS)

Outcome Measures

Primary Outcomes (1)

• Association between plasma NT-proBNP levels and the presence, extension and severity of angiographic lesions in patients with suspected CAD.

  Plasma NT-proBNP levels are quantified on the morning before coronary angiography using a highly sensitive electrochemiluminescence immunoassay (ECLIA) method (NT-proBNP, Roche Diagnostics, Germany), employing the Roche Modular Analytics E170 immunoassay analyzer AL. The aim of this study is to explore the association between these levels and the presence (critical vs non-critical), location (prognostic vs non-prognostic), severity (\>70%, 70-99%, 100%) and extent of obstructive lesions detected in a contemporary cohort of patients undergoing coronary angiography for suspected CAD. Coronary angiograms are independently evaluated by two experienced interventional cardiologists (C.G. and C.G.) who are blinded to the NT-proBNP levels.

  Plasma NT-proBNP levels are quantified on the morning before coronary angiography. The CAD burden is independently evaluated by two experienced interventional cardiologists periprocedurally and immediately after the coronary angiography.

Interventions

BNP DIAGNOSTIC_TEST

Measurement of plasma NT-proBNP level.

Eligibility Criteria

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

Study Population

Patients referred to San Raffaele Hospital between September 2021 and July 2024 for elective coronary angiography due to the suspected CAD (i.e. presence of suggestive signs or symptoms and positive non-invasive functional and/or anatomical tests).

You may qualify if:

• patient referred for elective coronary angiography due to suspected CAD.
• NT-proBNP measurement during hospitalization

You may not qualify if:

• heart failure
• severe valvular disease
• atrial fibrillation
• severe chronic kidney disease (eGFR \< 30 mL/min)
• prior coronary artery bypass grafting
• age over 80 years

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Study Sites (2)

IRCCS San Raffaele Hospital

Milan, Italy, 20132, Italy

COMPLETED

IRCCS San Raffaele Hospital

Milan, Italy, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Carlo Gaspardone

CONTACT

+393389920314; gaspardone.carlo@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: June 10, 2025
• Study Start: September 1, 2021
• Primary Completion: June 29, 2025
• Study Completion: July 31, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

IT (2)