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| ID | Type | Description | Link |
|---|---|---|---|
| 22HH7546 | Other Identifier | Imperial College London |
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| Name | Class |
|---|---|
| Royal Free Hospital NHS Foundation Trust | OTHER |
| Mid and South Essex NHS Foundation Trust | OTHER |
| St George's University Hospitals NHS Foundation Trust | OTHER |
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ORBITA-FIRE is a randomised, double-blinded, placebo controlled experimental study that will identify the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) thresholds that correlate with symptoms of angina for 58 patients measured invasively under experimental conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with stable angina |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rest-angina physiological assessment | Diagnostic Test | The degree of stenosis required to cause angina at rest will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR. |
| Measure | Description | Time Frame |
|---|---|---|
| The FFR and NHPR value at which the patient experiences angina in a rest state | Values 0.00-1.00 (Lower = More significant disease) | Intra-procedural |
| The FFR and NHPR value at which the patient experiences angina in an exercise state | Values 0.00-1.00 (Lower = More significant disease) | Intra-procedural |
| Measure | Description | Time Frame |
|---|---|---|
| The FFR difference between the rest and exercise states | Values 0.00-1.00 (Lower = More significant disease) | Intra-procedural |
| The NHPR difference between the rest and exercise states | Values 0.00-1.00 (Lower = More significant disease) |
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Inclusion Criteria:
Eligibility for percutaneous coronary intervention (PCI) due to angina or angina-equivalent symptoms on exertion
Anatomical evidence of significant single-vessel coronary stenosis defined by either:
Physiological evidence of ischaemia with a positive test on at least one of the following:
Exclusion Criteria:
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Patient with stable angina
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fiyyaz Ahmed-Jushuf, MBBS MRCP | Contact | 020 7594 5735 | fiyyaz.ahmed-jushuf09@imperial.ac.uk | |
| Rasha Al-Lamee, PhD MRCP | Contact | 020 7594 5735 | r.al-lamee13@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Rasha Al-Lamee, PhD MRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mid and South Essex NHS Foundation Trust | Recruiting | Basildon | United Kingdom |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust |
| OTHER_GOV |
| Portsmouth Hospitals NHS Trust | OTHER_GOV |
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| Exercise-angina physiological assessment | Diagnostic Test | The degree of stenosis required to cause angina during exercise will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR. |
|
| Intra-procedural |
| Angina severity score at the angina threshold | The patient scores the severity of the angina experienced during the procedure between 0-10 (Higher = More severe) | Intra-procedural |
| Angina similarity score at the angina threshold | The patient scores the similarity of the angina experienced during the procedure against the angina experienced before the procedure between 0-10 (Higher = Most similar) | Intra-procedural |
| Angina symptom type at the angina threshold | The patient will list all symptoms experienced at the angina threshold | Intra-procedural |
| Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust | Recruiting | Bournemouth | United Kingdom |
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| Imperial College NHS Trust | Recruiting | London | United Kingdom |
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| Royal Free Hospital NHS Foundation Trust | Recruiting | London | United Kingdom |
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| St George's University Hospitals NHS Foundation Trust | Recruiting | London | United Kingdom |
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| Portsmouth Hospitals NHS Trust | Recruiting | Portsmouth | United Kingdom |
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| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |