Clinical trial NCT04280575: Symptomatic Trial of Angina Assessment Prior to Revascularization
Official title: Symptomatic Trial of Angina Assessment Prior to Revascularization: A Placebo-controlled Experiment on Symptoms in Stable Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Angina, Stable
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
name: Mid and South Essex NHS Foundation Trust
First posted: 2020-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with single-vessel coronary artery disease with symptoms of stable angina

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.


Eligibility criteria: 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

Primary outcomes:
measure: Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery
timeFrame: 30 Days
Secondary outcomes:
measure: Change in angina symptom score
timeFrame: 30 Days
measure: Change in treadmill exercise time
timeFrame: 30 Days
measure: Change in treadmill time to chest pain
timeFrame: 30 Days
measure: Angina severity as assessed by Canadian Cardiovascular Society Class
timeFrame: 30 Days
measure: Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire.
timeFrame: 30 Days
measure: Quality of Life assessed with the EQ-5D-5L questionnaire
timeFrame: 30 Days
measure: Change in dobutamine stress echocardiography score
timeFrame: 30 Days
measure: Need for anti-anginal medication introduction and uptitration
timeFrame: 30 Days
measure: Anxiety as assessed by the GAD-7 Score
timeFrame: 30 days
measure: Depression as assessed by the PHQ-9 Score
timeFrame: 30 days
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Trust
state: Essex
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References: