ORBITA-STAR: Symptomatic Trial of Angina Assessment Prior to Revascularization

• Sponsor: Imperial College London (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04280575
• Collaborator: Imperial College Healthcare NHS Trust (Other), Mid and South Essex NHS Foundation Trust (Other)
• Enrollment: 65
• Locations: 2
• Anticipated Duration (Months): 26.5
• Patients Per Site: 32.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Angina, Stable	Procedure: Percutaneous coronary intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 65 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Symptomatic Trial of Angina Assessment Prior to Revascularization: A Placebo-controlled Experiment on Symptoms in Stable Coronary Artery Disease
• Actual Study Start Date: Jan 16, 2020
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Apr 1, 2022

Outcome Measures

Primary Outcome Measures

1. 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

1. Change in angina symptom score [30 Days]

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

2. Change in treadmill exercise time [30 Days]

3. Change in treadmill time to chest pain [30 Days]

4. Angina severity as assessed by Canadian Cardiovascular Society Class [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. [30 Days]

   Seattle Angina Questionnaire, (Lower Score = Better Outcome)

6. Quality of Life assessed with the EQ-5D-5L questionnaire [30 Days]

   (Lower Score = Better Outcome)

7. Change in dobutamine stress echocardiography score [30 Days]

   (Lower Score = Better Outcome)

8. Need for anti-anginal medication introduction and uptitration [30 Days]

9. Anxiety as assessed by the GAD-7 Score [30 days]

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

10. Depression as assessed by the PHQ-9 Score [30 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Trust	Basildon	Essex	United Kingdom
2	Imperial College Healthcare NHS Trust	London		United Kingdom	W12 0HS

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT04280575
• Other Study ID Numbers: 19HH5060
• First Posted: Feb 21, 2020
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable

Study Results

No Results Posted as of Aug 25, 2021