Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-11 @ 8:38 PM
Study NCT ID:
NCT05459051
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2022-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-04-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-07-13', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The FFR and NHPR value at which the patient experiences angina in a rest state', 'timeFrame': 'Intra-procedural', 'description': 'Values 0.00-1.00 (Lower = More significant disease)'}, {'measure': 'The FFR and NHPR value at which the patient experiences angina in an exercise state', 'timeFrame': 'Intra-procedural', 'description': 'Values 0.00-1.00 (Lower = More significant disease)'}], 'secondaryOutcomes': [{'measure': 'The FFR difference between the rest and exercise states', 'timeFrame': 'Intra-procedural', 'description': 'Values 0.00-1.00 (Lower = More significant disease)'}, {'measure': 'The NHPR difference between the rest and exercise states', 'timeFrame': 'Intra-procedural', 'description': 'Values 0.00-1.00 (Lower = More significant disease)'}, {'measure': 'Angina severity score at the angina threshold', 'timeFrame': 'Intra-procedural', 'description': 'The patient scores the severity of the angina experienced during the procedure between 0-10 (Higher = More severe)'}, {'measure': 'Angina similarity score at the angina threshold', 'timeFrame': 'Intra-procedural', 'description': '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)'}, {'measure': 'Angina symptom type at the angina threshold', 'timeFrame': 'Intra-procedural', 'description': 'The patient will list all symptoms experienced at the angina threshold'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Symptoms', 'Angina', 'Physiology', 'Placebo'], 'conditions': ['Stable Angina']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with stable angina', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligibility for percutaneous coronary intervention (PCI) due to angina or angina-equivalent symptoms on exertion\n* Anatomical evidence of significant single-vessel coronary stenosis defined by either:\n\n * ≥70% stenosis on invasive coronary angiography (ICA)\n * Severe stenosis on CT coronary angiography (CTCA)\n* Physiological evidence of ischaemia with a positive test on at least one of the following:\n\n * Stress echocardiography\n * Cardiac magnetic resonance perfusion\n * Myocardial perfusion scintigraphy\n * Invasive metrics of coronary physiology\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Recent acute coronary syndrome\n* Previous coronary artery by-pass graft\n* Significant left main stem disease\n* Multivessel disease (defined as \\>50% angiographic stenosis in other vessels)\n* Chronic total occlusion in the target artery\n* Moderate to severe valvular disease\n* Moderate to severe left ventricular impairment\n* Chronotropic incompetence with a pacemaker\n* Contraindication to PCI or a drug-eluting stents\n* Contraindication to antiplatelet therapy\n* Contraindication to adenosine\n* Moderate to severe respiratory disease\n* Physical inability to exercise\n* Pregnant\n* Inability to consent'}, 'identificationModule': {'nctId': 'NCT05459051', 'acronym': 'ORBITA-FIRE', 'briefTitle': 'Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina', 'orgStudyIdInfo': {'id': 'P91528'}, 'secondaryIdInfos': [{'id': '22HH7546', 'type': 'OTHER', 'domain': 'Imperial College London'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with stable angina', 'description': '* Symptomatic\n* Anatomically severe single-vessel coronary artery disease\n* Physiological evidence of myocardial ischaemia', 'interventionNames': ['Diagnostic Test: Rest-angina physiological assessment', 'Diagnostic Test: Exercise-angina physiological assessment']}], 'interventions': [{'name': 'Rest-angina physiological assessment', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Patients with stable angina']}, {'name': 'Exercise-angina physiological assessment', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Patients with stable angina']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basildon', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Thomas Keeble', 'role': 'CONTACT', 'email': 'thomas.keeble@btuh.nhs.uk'}], 'facility': 'Mid and South Essex NHS Foundation Trust', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'city': 'Bournemouth', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': "Peter O'Kane", 'role': 'CONTACT', 'email': "peter.o'kane@rbch.nhs.uk"}], 'facility': 'Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Fiyyaz Ahmed-Jushuf', 'role': 'CONTACT', 'email': 'fiyyaz.ahmed-jushuf09@imperial.ac.uk'}], 'facility': 'Imperial College NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Tushar Kotecha', 'role': 'CONTACT', 'email': 'tushar.kotecha@nhs.net'}], 'facility': 'Royal Free Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'James Spratt', 'role': 'CONTACT', 'email': 'james.spratt@nhs.net'}], 'facility': "St George's University Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Portsmouth', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Peter Haworth', 'role': 'CONTACT', 'email': 'peter.haworth@porthosp.nhs.uk'}], 'facility': 'Portsmouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}], 'centralContacts': [{'name': 'Fiyyaz Ahmed-Jushuf, MBBS MRCP', 'role': 'CONTACT', 'email': 'fiyyaz.ahmed-jushuf09@imperial.ac.uk', 'phone': '020 7594 5735'}, {'name': 'Rasha Al-Lamee, PhD MRCP', 'role': 'CONTACT', 'email': 'r.al-lamee13@imperial.ac.uk', 'phone': '020 7594 5735'}], 'overallOfficials': [{'name': 'Rasha Al-Lamee, PhD MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal Free Hospital NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Mid and South Essex NHS Foundation Trust', 'class': 'OTHER'}, {'name': "St George's University Hospitals NHS Foundation Trust", 'class': 'OTHER'}, {'name': 'Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust', 'class': 'OTHER_GOV'}, {'name': 'Portsmouth Hospitals NHS Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}