A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina

Stable Angina Clinical Trial

— ORBITA-CTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142215
• Other study ID #: 299940
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: August 2023
• Source: Mid and South Essex NHS Foundation Trust
• Contact: John Davies, MRCP PhD
• Phone: 01268 524900
• Email: john.davies32[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ORBITA-CTO Pilot is a double blinded randomised placebo-controlled trial comparing the effects of chronic total occlusion percutaneous coronary intervention versus placebo on symptoms of angina in patients with background optimal medical therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Chronic Total Occlusion of Coronary Artery
• Stable Angina

Intervention

Procedure:
• Percutaneous coronary intervention
Percutaneous coronary intervention using drug eluting stents and contemporary CTO PCI techniques on background of optimal medical therapy.
• Placebo percutaneous coronary intervention
Placebo percutaneous coronary intervention procedure on background of optimal medical therapy.

Locations

Country	Name	City	State
United Kingdom	Essex Cardiothoracic Centre	Basildon	Essex
United Kingdom	Royal Bournemouth Hospital	Bournemouth

Sponsors (2)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust	Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in angina symptom ordinal scale score between groups	Change in angina symptom ordinal scale score between groups	24 & 26 weeks
Secondary	Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)	Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)	24 & 26 weeks
Secondary	SAQ summary score	SAQ summary score	24 & 26 weeks
Secondary	Quality of life as measured by EQ-5D-5L	Quality of life as measured by EQ-5D-5L	24 & 26 weeks
Secondary	Change in Rose dyspnea scale	Change in Rose dyspnea scale	24 & 26 weeks
Secondary	Change in peak VO2 and VO2 at AT	Change in peak VO2 and VO2 at AT	24 weeks
Secondary	Fidelity of blinding using Bang's blinding index (BI)	Fidelity of blinding using Bang's blinding index (BI)	24 weeks
Secondary	Protocol adherence	Proportion of participants adherent to allocated randomised treatment	26 weeks