Symptomatic Trial of Angina Assessment Prior to Revascularization

Completed

• Conditions: Coronary Artery Disease; Angina, Stable

• Registration Number: NCT04280575
• Lead Sponsor: Imperial College London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-16
• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-21
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Trust; 🇬🇧 Basildon, Essex, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom