Using CT scans to improve heart artery procedures

Interest of Coronary CT Scan Before Complex Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI).

This study is testing if using CT scans before heart artery procedures can help patients with complex blockages have better results and less exposure to radiation and contrast agents.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Elsan (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Ollioules)
• Trial ID: NCT04549896 on ClinicalTrials.gov

What this trial studies

This study investigates the use of computed tomography (CT) scans prior to percutaneous coronary intervention (PCI) for patients with chronic total occlusion (CTO) of coronary arteries. By obtaining detailed anatomical information from CT scans, the researchers aim to enhance the success rate of PCI, reduce the amount of radiation exposure, minimize the use of contrast agents, and streamline the overall procedure. The study focuses on patients with complex cases of CTO, as defined by the Japan Chronic Total Occlusion (J-CTO) score, to determine if pre-procedural imaging can lead to better outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with chronic total occlusion of coronary arteries and specific symptoms or conditions indicating the need for intervention.

Not a fit: Patients with a J-CTO score of 0 or 1, indicating less complex cases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer and more effective heart procedures for patients with chronic total occlusion.

How similar studies have performed: While the use of CT scans in coronary interventions is gaining interest, this specific approach in complex CTO cases is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Male or female ≥ 18 years old and ≤ 90 years old,
2. BMI ≤ 40 kg/m²,
3. Dated and signed informed consent, before any study-related procedures
4. Ability to understand and comply with the study procedures,
5. Affiliate or recipient of a social security scheme,
6. Coronary artery chronic total occlusion (TIMI 0 flow from \> 3 months) associated with myocardial viability (intended like normokinetic/hypokinetic wall motion or instrumental data in favor of viability) associated with ≥ CCS2 angina or ≥ NHYA2 dyspnea or documented ischemia or ejection fraction \<50%.
7. Coronary angiography J-CTO score ≥ 2 (complex cases)

Exclusion Criteria:

1. Pregnant or breastfeeding woman,
2. Adults patients protected by law,
3. Very frequent and irregular cardiac rhythm (\>100/min.),
4. More than one CTO to be treated by PCI,
5. Coronary angiography J-CTO (Japan Chronic Total Occlusion) score 0/1
6. Hemodynamic instability,
7. Anemia \< 9g/dl,
8. Gastrointestinal bleeding,
9. Thrombocytopenia with \< 50 000/mm3 platelets count,
10. Severe valvular disease associated
11. CT-Scan performed as part of the standard of care pathology diagnosis, before the inclusion

Where this trial is running

Ollioules

• Polyclinique Les Fleurs — Ollioules, France (Recruiting)

Study contacts

• Study coordinator: Eugenio LA SCALA, MD

Conditions Total Occlusion of Coronary Artery