Chronic Coronary SyndromeBNP-CADNCT07013344
Association of Plasma N-terminal Pro-Brain Natriuretic Peptide Levels With the Burden of Coronary Artery Disease
An observational study of Chronic Coronary Syndrome and Chronic Coronary Total Occlusion, run by IRCCS Ospedale San Raffaele at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome, Chronic Coronary Total Occlusion, Coronary Arterial Disease (CAD)
- What is being tested?
- BNP
- How many people
- 800 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2021to 31 Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- patient referred for elective coronary angiography due to suspected CAD.
- NT-proBNP measurement during hospitalization
Who cannot join
- heart failure
- severe valvular disease
- atrial fibrillation
- severe chronic kidney disease (eGFR < 30 mL/min)
- prior coronary artery bypass grafting
- age over 80 years
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 1 recruiting
- Completed
IRCCS San Raffaele Hospital
Milan, Italy, 20132
- Recruiting
IRCCS San Raffaele Hospital
Milan, Italy, 20132
Carlo Gaspardone, 0226437373, gaspardone.carlo@hsr.it
About this study
Official title: Association of Plasma N-terminal Pro-Brain Natriuretic Peptide Levels With the Burden of Coronary Artery Disease: Insights From a Real-World Cohort
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.
Read the detailed description
The investigators prospectively measured plasma NT-proBNP levels in consecutive patients referred to the center for elective diagnostic coronary angiography due to symptoms or signs of coronary artery disease over a two- year period. Patients with conditions known to elevate NT-proBNP levels, including heart failure, severe valvular disease, atrial fibrillation, severe chronic kidney disease (eGFR < 30 mL/min), prior coronary artery bypass grafting, or age over 80 years, were excluded.
- Conditions
- Chronic Coronary Syndrome, Chronic Coronary Total Occlusion, Coronary Arterial Disease (CAD), Stable Chronic Angina, NT-pro-BNP
- Being tested
- BNP
- Keywords
- NT-pro-BNP, Coronary Arterial Disease (CAD), Chronic Coronary Syndrome (CCS)
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNPDiagnostic test
Measurement of plasma NT-proBNP level.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Sep 2021
- Primary completion29 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Gaspardone, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013344
- Sponsor's protocol ID
- BNP-CAD-HSR-2025
- Acronym
- BNP-CAD
- Status last verified
- Jun 2025
- First submitted
- 27 Mar 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schivalocchi M, Mazza R, Gaspardone C, Rigatelli A, Morosato M, Costa P, Gentile A, Tripoli A, Di Palma V, Salerno A, Maccagni D, Montorfano M, Margonato A, Metra M, Godino C. NT-proBNP as a marker of coronary artery disease burden in chronic coronary syndromes. Int J Cardiol. 2026 Aug 24:134752. doi: 10.1016/j.ijcard.2026.134752. Online ahead of print.
PubMed 42637094
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Plasma N-terminal Pro-Brain Natriuretic Peptide Levels With the Burden of Coronary Artery Disease: Insights From a Real-World Cohort
- ClinicalTrials.gov ID
- NCT07013344
- Acronym / sponsor ID
- BNP-CAD / BNP-CAD-HSR-2025
- 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)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 29 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators prospectively measured plasma NT-proBNP levels in consecutive patients referred to the center for elective diagnostic coronary angiography due to symptoms or signs of coronary artery disease over a two- year period. Patients with conditions known to elevate NT-proBNP levels, including heart failure, severe valvular disease, atrial fibrillation, severe chronic kidney disease (eGFR < 30 mL/min), prior coronary artery bypass grafting, or age over 80 years, were excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- patient referred for elective coronary angiography due to suspected CAD.
- NT-proBNP measurement during hospitalization
Key exclusion criteria (6 listed)
- heart failure
- severe valvular disease
- atrial fibrillation
- severe chronic kidney disease (eGFR < 30 mL/min)
- prior coronary artery bypass grafting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNPMeasurement of plasma NT-proBNP level. | Diagnostic test | – |
Primary outcome
Association between plasma NT-proBNP levels and the presence, extension and severity of angiographic lesions in patients with suspected CAD.
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Derived from this study: PubMed 42637094Schivalocchi M, Mazza R, Gaspardone C, Rigatelli A, Morosato M, Costa P, Gentile A, Tripoli A, Di Palma V, Salerno A, Maccagni D, Montorfano M, Margonato A, Metra M, Godino C. NT-proBNP as a marker of coronary artery disease burden in chronic coronary syndromes. Int J Cardiol. 2026 Aug 24:134752. doi: 10.1016/j.ijcard.2026.134752. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Coronary Syndrome and Chronic Coronary Total Occlusion, run by IRCCS Ospedale San Raffaele at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlo Gaspardone (+393389920314, gaspardone.carlo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between plasma NT-proBNP levels and the presence, extension and severity of angiographic lesions in patients with suspected CAD. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07013344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.