ClinicalTrials.gg
RecruitingNCT07013344BNP-CADUpdated Jun 10, 2025

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

An observational study in Chronic Coronary Syndrome, Chronic Coronary Total Occlusion and Coronary Arterial Disease (CAD), sponsored by IRCCS Ospedale San Raffaele. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by IRCCS Ospedale San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Sep 2021; still recruiting 5 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

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

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Keywords

  • NT-pro-BNP
  • Coronary Arterial Disease (CAD)
  • Chronic Coronary Syndrome (CCS)
03

In context

Angina, Stable

343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.

This study's planned enrollment of 800 is above the median of 508 across 103 observational studies indexed under Angina, Stable.

Browse Angina, Stable studies →

Lead sponsor

IRCCS Ospedale San Raffaele is the lead sponsor of 36 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • heart failure
  • severe valvular disease
  • atrial fibrillation
  • severe chronic kidney disease ( \< 30 mL/min)
  • prior coronary artery bypass grafting
  • age over 80 years
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • Diagnostic testBNP

    Measurement of plasma NT-proBNP level.

06

What researchers measure

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.

    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.

07

Study locations

1 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2021 (actual). Primary completion is estimated for Jun 2025, 45 months after the start.

Of 52 observational studies under Angina, Stable, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 79. This study's planned 45 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2025
First posted
Jun 10, 2025
StartActual
Sep 1, 2021
Primary completionEst.
Jun 29, 2025
CompletionEst.
Jul 31, 2025
Last update
Jun 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07013344
Lead sponsor
IRCCS Ospedale San Raffaele
Responsible party
Carlo Gaspardone (Principal Investigator, IRCCS Ospedale San Raffaele) — Principal investigator
First posted
Jun 10, 2025
Start date
Sep 1, 2021
Primary completion
Jun 29, 2025 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
Jun 10, 2025

Study contacts

Carlo Gaspardone
Contact
gaspardone.carlo@hsr.it
+393389920314

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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