Comparing a heart procedure to a placebo for treating stable angina

ORBITA-CTO Pilot: a Comparison of the Impact of CTO PCI Versus Placebo on Angina in Patients with Background Optimal Medical Therapy - a Pilot Study

This study is testing if a heart procedure can help people with stable angina feel better compared to a placebo while they are already on the best medical treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mid and South Essex NHS Foundation Trust (other)
• Locations: 2 sites (Basildon, Essex and 1 other locations)
• Trial ID: NCT05142215 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of chronic total occlusion percutaneous coronary intervention (CTO PCI) compared to a placebo in alleviating symptoms of stable angina in patients already receiving optimal medical therapy. It is a double-blinded, randomized, placebo-controlled trial designed to assess whether the intervention can provide significant relief from angina symptoms. Patients will be monitored for changes in their angina symptoms and overall heart function following the procedure. The study aims to provide insights into the benefits of CTO PCI in a specific patient population.

Who should consider this trial

Good fit: Ideal candidates are patients with stable angina symptoms related to a single vessel chronic total occlusion who have been accepted for the CTO PCI procedure.

Not a fit: Patients with multiple significant coronary artery stenoses or those not experiencing typical angina symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from stable angina due to chronic total occlusion.

How similar studies have performed: Other studies have shown promising results with similar interventions, but this specific approach is being evaluated for the first time in this context.

Eligibility criteria

Inclusion Criteria:

ORBITA CTO will enrol patients who meet all 5 of the following criteria:

1. Accepted for CTO PCI procedure by a specialist CTO operator.
2. Patients with symptoms related to a single vessel CTO (≥3 months duration, or probable CTO where duration is unknown) in a vessel of at least 2.5mm diameter without angiographically significant (LMS ≥50%, LAD/Cx/RCA/Graft ≥70%, ≥2mm diameter) coronary artery stenosis in remaining non-CTO vessels.

   Symptoms are:

   a) Typical exertional angina defined as: i) constricting discomfort in the front of the chest or in the neck, jaw, shoulder or arm ii) precipitated by physical exertion iii) relieved by rest or nitrates within 5 minutes b) Angina symptoms at rest (including decubitus angina and post-prandial angina).

   c) Shortness of breath on exertion considered to be angina equivalent.
3. Clinical evidence of ischaemia in CTO territory on dobutamine stress echocardiography, nuclear myocardial perfusion scan, stress perfusion CMR or PET).
4. Evidence of viability: If left ventricular angiogram or echocardiogram demonstrates LV impairment or RWMA then viability must be demonstrated.
5. J-CTO score ≤ 3.

Exclusion Criteria:

1. Acute coronary syndrome within 4 weeks.
2. PCI to non-CTO lesion in prior 4 weeks as part of ACS or elective PCI.
3. Non-revascularised clinically important non-CTO vessel.
4. Proven ischaemia (invasive or non-invasive) in non-culprit territory.
5. Contraindications to PCI or drug-eluting stent (DES) implantation.
6. Inability to tolerate or contraindication to DAPT.
7. Severe valvular heart disease.
8. Severe chronic pulmonary disease (FEV1 \<30% of predicted value).
9. Severe musculoskeletal disease resulting in immobility.
10. Life expectancy \<2years.
11. Pregnancy.
12. Age \<18years.
13. Inability to consent.

Where this trial is running

Basildon, Essex and 1 other locations

• Essex Cardiothoracic Centre — Basildon, Essex, United Kingdom (RECRUITING)
• Royal Bournemouth Hospital — Bournemouth, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: John Davies, MRCP PhD — Essex Cardiothoracic Centre, UK
• Study coordinator: John Davies, MRCP PhD

Conditions: Stable Angina, Chronic Total Occlusion of Coronary Artery, Angina, Chronic total occlusion, Angioplasty