Implementation of Contemporary Coronary CT Angiography in Clinical Practice

NCT06273033 | Recruiting

• 1 other identifier: CONCORDE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary CT angiography (CCTA) has been recognized as the first-line diagnostic test for most patients with suspected coronary syndrome, often acting as a gatekeeper for invasive coronary angiography. It is therefore pivotal to understand instances of discrepancies that are encountered in clinical practice. Moreover, most of the literature on this topic relies on obsolete machines or definitions of coronary artery stenosis that cannot be defined as severe. The investigators aim 1) to report the real word data on the performance of last-generation CCTA in identifying obstructive coronary artery disease (also considering different thresholds of stenosis, i.e., moderate or severe) and 2) to identify predictors of discrepancies.

Conditions

Coronary Artery Disease of Significant Bypass Graft; Coronary Syndrome; Coronary Arteriosclerosis

Keywords

Coronary Artery Disease; Coronary Computed Tomography Angiography; Invasive Coronary Angiography

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a patient with suspected CAD.

  One month.

Secondary Outcomes (3)

• Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a patient with suspected CAD.

  One month.

• Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a vessel of a patient with suspected CAD

  One month.

• Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a vessel of a patient with suspected CAD

  One month.

Study Arms (1)

Patients who have undergone last-generation CCTA and ICA.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Real-world patients who underwent a last-generation CCTA and an ICA within one month from 2010 until 2023

You may qualify if:

• CCTA with \>64 rows
• ICA performed within one month from CCTA

You may not qualify if:

• \- age\<18 years

Sponsors & Collaborators

• Humanitas Hospital, Italy: lead

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Angina, Unstable; Coronary Artery Disease

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; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Giulio Stefanini, MD, PhD

  IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy

  PRINCIPAL INVESTIGATOR

• Marco Francone, MD

  IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy

  PRINCIPAL INVESTIGATOR

• Carlo Andrea Pivato, MD

  IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Andrea Pivato, MD

CONTACT

+39 02 8224 7235; carlo.pivato@humanitas.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: October 10, 2023
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

IT (1)