Clinical trial NCT05142215: A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stable Angina
Chronic Total Occlusion of Coronary Artery
Keywords: Angina
Chronic total occlusion
Angioplasty
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2021-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Change in angina symptom ordinal scale score between groups
timeFrame: 24 & 26 weeks
Secondary outcomes:
measure: Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)
timeFrame: 24 & 26 weeks
measure: SAQ summary score
timeFrame: 24 & 26 weeks
measure: Quality of life as measured by EQ-5D-5L
timeFrame: 24 & 26 weeks
measure: Change in Rose dyspnea scale
timeFrame: 24 & 26 weeks
measure: Change in peak VO2 and VO2 at AT
timeFrame: 24 weeks
measure: Fidelity of blinding using Bang's blinding index (BI)
timeFrame: 24 weeks
measure: Protocol adherence
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Essex Cardiothoracic Centre
state: Essex
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
Study officials:
affiliation: Essex Cardiothoracic Centre, UK
name: John Davies, MRCP PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Essex Cardiothoracic Centre, UK
name: Sarosh Khan, MRCP
role: STUDY_DIRECTOR
References: