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| Name | Class |
|---|---|
| Volcano Corporation | INDUSTRY |
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In this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.
The investigators will perform a multi-centre prospective randomised double-blinded comparison of the treatment of stable angina with percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) versus a sham procedure and OMT. Two hundred patients with stable angina and one or more angiographically significant coronary stenosis of 70% or more in a single vessel that is suitable for angioplasty will be recruited. Baseline investigation of functional capacity and myocardial ischaemic burden will be performed. This will be followed by a coronary angiogram and invasive physiological investigation followed by randomisation to PCI or a sham procedure. Follow-up investigation of functional capacity and myocardial ischaemic burden at 6 weeks will then be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary angioplasty and optimum medical therapy | Active Comparator | Percutaneous coronary intervention and optimal medical therapy |
|
| Sham procedure and optimum medical therapy | Placebo Comparator | Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary angioplasty | Procedure | Percutaneous coronary intervention with drug-eluting stents and modern techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Time on Treadmill | Measured in seconds on Modified Bruce exercise treadmill protocol | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin E Davies, MRCP, PhD | Imperial College London | Principal Investigator |
| Darrel P Francis, MRCP, MD | Imperial College London | Study Chair |
| Rasha K Al-Lamee, MRCP | Imperial College London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Sussex Healthcare NHS Trust | Saint Leonards-on-Sea | East Sussex | TN37 7RD | United Kingdom | ||
| Basildon and Thurrock University Hospitals NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29103656 | Result | Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, Keeble T, Mielewczik M, Kaprielian R, Malik IS, Nijjer SS, Petraco R, Cook C, Ahmad Y, Howard J, Baker C, Sharp A, Gerber R, Talwar S, Assomull R, Mayet J, Wensel R, Collier D, Shun-Shin M, Thom SA, Davies JE, Francis DP; ORBITA investigators. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018 Jan 6;391(10115):31-40. doi: 10.1016/S0140-6736(17)32714-9. Epub 2017 Nov 2. | |
| 35618353 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Coronary Angioplasty and Optimum Medical Therapy | Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques |
| FG001 | Sham Procedure and Optimum Medical Therapy | Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Coronary Angioplasty and Optimum Medical Therapy | Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques |
| BG001 | Sham Procedure and Optimum Medical Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exercise Time on Treadmill | Measured in seconds on Modified Bruce exercise treadmill protocol | No exercise time data available for 1 patient in PCI group and 5 patients in placebo group. | Posted | Mean | 95% Confidence Interval | seconds | 6 weeks |
|
Total study time 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coronary Angioplasty and Optimum Medical Therapy | Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rasha Al-Lamee | Imperial College London | +447976276923 | r.al-lamee13@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2014 | Mar 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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|
| Basildon |
| SS16 5NL |
| United Kingdom |
| The Royal Bournemouth and Christchurch Hospitals NHS Trust | Bournemouth | BH7 7DW | United Kingdom |
| Royal Devon & Exeter Foundation Trust | Exeter | EX2 5DW | United Kingdom |
| Imperial College Healthcare NHS Trust | London | United Kingdom |
| Derived |
| Rajkumar CA, Wereski R, Parsonage W, Cullen L, Khamis R, Foley M, Harrell FE Jr, Shun-Shin MJ, Mills NL, Al-Lamee RK. Association Between High-Sensitivity Cardiac Troponin, Myocardial Ischemia, and Revascularization in Stable Coronary Artery Disease. J Am Coll Cardiol. 2022 May 31;79(21):2185-2187. doi: 10.1016/j.jacc.2022.03.369. No abstract available. |
| 34340523 | Derived | Rajkumar CA, Shun-Shin M, Seligman H, Ahmad Y, Warisawa T, Cook CM, Howard JP, Ganesananthan S, Amarin L, Khan C, Ahmed A, Nowbar A, Foley M, Assomull R, Keenan NG, Sehmi J, Keeble TR, Davies JR, Tang KH, Gerber R, Cole G, O'Kane P, Sharp ASP, Khamis R, Kanaganayagam G, Petraco R, Ruparelia N, Malik IS, Nijjer S, Sen S, Francis DP, Al-Lamee R. Placebo-Controlled Efficacy of Percutaneous Coronary Intervention for Focal and Diffuse Patterns of Stable Coronary Artery Disease. Circ Cardiovasc Interv. 2021 Aug;14(8):e009891. doi: 10.1161/CIRCINTERVENTIONS.120.009891. Epub 2021 Aug 3. |
| 33563623 | Derived | McCreanor V, Nowbar A, Rajkumar C, Barnett AG, Francis D, Graves N, Boden WE, Weintraub WS, Al-Lamee R, Parsonage WA. Cost-effectiveness analysis of percutaneous coronary intervention for single-vessel coronary artery disease: an economic evaluation of the ORBITA trial. BMJ Open. 2021 Feb 9;11(2):e044054. doi: 10.1136/bmjopen-2020-044054. |
| 33496201 | Derived | Foley M, Rajkumar CA, Shun-Shin M, Ganesananthan S, Seligman H, Howard J, Nowbar AN, Keeble TR, Davies JR, Tang KH, Gerber R, O'Kane P, Sharp ASP, Petraco R, Malik IS, Nijjer S, Sen S, Francis DP, Al-Lamee R. Achieving Optimal Medical Therapy: Insights From the ORBITA Trial. J Am Heart Assoc. 2021 Feb 2;10(3):e017381. doi: 10.1161/JAHA.120.017381. Epub 2021 Jan 26. |
| 31707827 | Derived | Al-Lamee RK, Shun-Shin MJ, Howard JP, Nowbar AN, Rajkumar C, Thompson D, Sen S, Nijjer S, Petraco R, Davies J, Keeble T, Tang K, Malik I, Bual N, Cook C, Ahmad Y, Seligman H, Sharp ASP, Gerber R, Talwar S, Assomull R, Cole G, Keenan NG, Kanaganayagam G, Sehmi J, Wensel R, Harrell FE Jr, Mayet J, Thom S, Davies JE, Francis DP. Dobutamine Stress Echocardiography Ischemia as a Predictor of the Placebo-Controlled Efficacy of Percutaneous Coronary Intervention in Stable Coronary Artery Disease: The Stress Echocardiography-Stratified Analysis of ORBITA. Circulation. 2019 Dec 10;140(24):1971-1980. doi: 10.1161/CIRCULATIONAHA.119.042918. Epub 2019 Nov 11. |
| 29789302 | Derived | Al-Lamee R, Howard JP, Shun-Shin MJ, Thompson D, Dehbi HM, Sen S, Nijjer S, Petraco R, Davies J, Keeble T, Tang K, Malik IS, Cook C, Ahmad Y, Sharp ASP, Gerber R, Baker C, Kaprielian R, Talwar S, Assomull R, Cole G, Keenan NG, Kanaganayagam G, Sehmi J, Wensel R, Harrell FE, Mayet J, Thom SA, Davies JE, Francis DP. Fractional Flow Reserve and Instantaneous Wave-Free Ratio as Predictors of the Placebo-Controlled Response to Percutaneous Coronary Intervention in Stable Single-Vessel Coronary Artery Disease. Circulation. 2018 Oct 23;138(17):1780-1792. doi: 10.1161/CIRCULATIONAHA.118.033801. |
Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 105 |
| 4 |
| 105 |
| 0 |
| 105 |
| EG001 | Sham Procedure and Optimum Medical Therapy | Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques | 0 | 95 | 14 | 95 | 0 | 95 |
| Acute confusion | Nervous system disorders | Systematic Assessment |
|
| Crossover to PCI | Cardiac disorders | Systematic Assessment |
|
| Wire snapped required snare retrieval | Cardiac disorders | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | Systematic Assessment |
|
| Hospitalisation for atypical chest pain | Cardiac disorders | Systematic Assessment |
|
| Hospitalisation for right heart failure | Cardiac disorders | Systematic Assessment |
|
| Hospitalisation for leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Severe drug reaction | Immune system disorders | Systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |