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Completed

NCT Number: NCT04280575

Symptomatic Trial of Angina Assessment Prior to Revascularization

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Severe valvular disease
  • Severe LV systolic impairment
  • Severe respiratory disease
  • Life expectancy less than 2 years, pregnancy, unable to consent

Treatment and study plan

Percutaneous coronary intervention

Procedure

Coronary artery stenting for stable angina

Other names: PCI

Primary outcomes

  1. 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

  1. Change in angina symptom score

    Time frame: 30 Days

    Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome)

  2. Change in treadmill exercise time

    Time frame: 30 Days

  3. Change in treadmill time to chest pain

    Time frame: 30 Days

  4. Angina severity as assessed by Canadian Cardiovascular Society Class

    Time frame: 30 Days

    Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome)

  5. Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire.

    Time frame: 30 Days

    Seattle Angina Questionnaire, (Lower Score = Better Outcome)

  6. Quality of Life assessed with the EQ-5D-5L questionnaire

    Time frame: 30 Days

    (Lower Score = Better Outcome)

  7. Change in dobutamine stress echocardiography score

    Time frame: 30 Days

    (Lower Score = Better Outcome)

  8. Need for anti-anginal medication introduction and uptitration

    Time frame: 30 Days

  9. Anxiety as assessed by the GAD-7 Score

    Time frame: 30 days

    Generalised anxiety and depression - 7 Score. (Lower Score = Better Outcome)

  10. Depression as assessed by the PHQ-9 Score

    Time frame: 30 days

    Patient Health Questionnaire - 9. (Lower Score = Better Outcome)

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Imperial College Healthcare NHS Trust
  • Mid and South Essex NHS Foundation Trust

Registry information

Official study title

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

Acronym: ORBITA-STAR

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2020
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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