Symptomatic Trial of Angina Assessment Prior to Revascularization

Coronary Artery Disease Clinical Trial

— ORBITA-STAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280575
• Other study ID #: 19HH5060
• Status: Completed
• Start date: January 16, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: September 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous coronary intervention
Coronary artery stenting for stable angina

Locations

Country	Name	City	State
United Kingdom	Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Trust	Basildon	Essex
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (3)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery	Similarity Score (1-10) (Higher Score = Better Outcome)	30 Days
Secondary	Change in angina symptom score	Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome)	30 Days
Secondary	Change in treadmill exercise time		30 Days
Secondary	Change in treadmill time to chest pain		30 Days
Secondary	Angina severity as assessed by Canadian Cardiovascular Society Class	Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome)	30 Days
Secondary	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
Secondary	Quality of Life assessed with the EQ-5D-5L questionnaire	(Lower Score = Better Outcome)	30 Days
Secondary	Change in dobutamine stress echocardiography score	(Lower Score = Better Outcome)	30 Days
Secondary	Need for anti-anginal medication introduction and uptitration		30 Days
Secondary	Anxiety as assessed by the GAD-7 Score	Generalised anxiety and depression - 7 Score. (Lower Score = Better Outcome)	30 days
Secondary	Depression as assessed by the PHQ-9 Score	Patient Health Questionnaire - 9. (Lower Score = Better Outcome)	30 days