Symptomatic Trial of Angina Assessment Prior to Revascularization (ORBITA-STAR)

Symptomatic Trial of Angina Assessment Prior to Revascularization: A Placebo-controlled Experiment on Symptoms in Stable Coronary Artery Disease

The principal objective of this research is to determine whether symptoms, induced by confirmed experimental ischaemia, can help us predict which patients will respond to PCI.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Angina, Stable
• Intervention / Treatment: Procedure: Percutaneous coronary intervention

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

• Study Contact: Name: Rasha K Al-Lamee; Phone Number: +44 208 082 5109; Email: r.al-lamee13@imperial.ac.uk
• Study Contact Backup: Name: Christopher A Rajkumar; Phone Number: +44 208 082 5109; Email: christopher.rajkumar07@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0HS
    • Imperial College Healthcare NHS Trust
  • Essex
    • Basildon, Essex, United Kingdom
      • Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with single-vessel coronary artery disease with symptoms of stable angina

Description

Inclusion Criteria:

1. Angina or angina-equivalent symptoms
2. Anatomical evidence of a significant single vessel coronary stenosis on diagnostic coronary angiography indicating ≥ 70% stenosis
3. Referred for percutaneous coronary intervention for treatment of stable angina

Exclusion Criteria:

1. Age younger than 18
2. Age older than 85
3. Recent acute coronary syndrome
4. Multivessel coronary artery disease
5. Previous coronary artery bypass graft surgery
6. Significant left main stem coronary disease
7. Chronic total occlusion in the target vessel
8. Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
9. Contraindication to antiplatelet therapy
10. Contraindication to adenosine infusion
11. Severe valvular disease
12. Severe LV systolic impairment
13. Severe respiratory disease
14. Life expectancy less than 2 years, pregnancy, unable to consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery	Similarity Score (1-10) (Higher Score = Better Outcome)	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in angina symptom score	Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome)	30 Days
Change in treadmill exercise time		30 Days
Change in treadmill time to chest pain		30 Days
Angina severity as assessed by Canadian Cardiovascular Society Class	Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome)	30 Days
Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire.	Seattle Angina Questionnaire, (Lower Score = Better Outcome)	30 Days
Quality of Life assessed with the EQ-5D-5L questionnaire	(Lower Score = Better Outcome)	30 Days
Change in dobutamine stress echocardiography score	(Lower Score = Better Outcome)	30 Days
Need for anti-anginal medication introduction and uptitration		30 Days
Anxiety as assessed by the GAD-7 Score	Generalised anxiety and depression - 7 Score. (Lower Score = Better Outcome)	30 days
Depression as assessed by the PHQ-9 Score	Patient Health Questionnaire - 9. (Lower Score = Better Outcome)	30 days

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Mid and South Essex NHS Foundation Trust; Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: 19HH5060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No