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

Imperial College London2 sites in 1 country80 target enrollmentJanuary 16, 2020

ConditionsCoronary Artery Disease Angina, Stable

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Imperial College London
Enrollment: 80
Locations: 2
Primary Endpoint: Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 16, 2020

End Date

May 1, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Imperial College London

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Age younger than 18
•Age older than 85
•Recent acute coronary syndrome
•Multivessel coronary artery disease
•Previous coronary artery bypass graft surgery
•Significant left main stem coronary disease
•Chronic total occlusion in the target vessel
•Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
•Contraindication to antiplatelet therapy
•Contraindication to adenosine infusion

Outcomes

Primary Outcomes

Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery

Time Frame: 30 Days

Similarity Score (1-10) (Higher Score = Better Outcome)

Secondary Outcomes

Change in angina symptom score(30 Days)
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)
Quality of Life assessed with the EQ-5D-5L questionnaire(30 Days)
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)
Depression as assessed by the PHQ-9 Score(30 days)
Angina severity as assessed by Canadian Cardiovascular Society Class(30 Days)
Anxiety as assessed by the GAD-7 Score(30 days)