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The expected outcome of better and improved patency of bypass grafts and its direct relation to pre-operative iFR measurements of stenosis as compared to direct visual physiology of stenosis in the coronary angiogram.
To establish the correlation between the use of intracoronary physiology and improved graft patency at 12 months for patients undergoing CABG surgery.
It is a minimum of 28 and a maximum of 100 patients single-centre proof or concept/ observational study/ pilot study.
Patients suffering from coronary artery disease undergo coronary artery bypass grafting surgery (CABG) as the standard of care. The selection of which vessels to bypass is usually at the discretion of the surgeon forming an opinion based on the pre-operative angiographic imaging. Intra-coronary physiology (iFR measurements) is more accurate to determine the level of damage to the coronary arteries; however, currently it is not used for CABG pre-assessment, but only for percutaneous intervention also known as stenting as it has been shown to improve outcomes. Although, the use of intracoronary physiology has not been extensively studied or validated in patients undergoing CABG.
Patients with multi-vessel coronary artery disease (CAD) who are planned for surgical revascularization with coronary artery bypass grafting (CABG), will have iFR measurement taken during invasive coronary angiography as part of standard care, they will undergo CABG and will have echocardiography at 3 months and computed tomography coronary angiography (CTCA) at 12 months.
Early graft failure will be assessed by the presentation of any clinical symptoms, major adverse cardiovascular and cerebrovascular events (MACCE) and echocardiography at 3 months. The endpoint will be graft patency as assessed by CT coronary angiography at 12 months.
Anticipated recruitment is 12-24 months. Follow-up with echocardiography at 3 months and a CTCA at 12 months. Quality of Life questionnaire will be completed by the patient at 3 and 12 months during the follow-up appointment.
Patients will continue on optimal medical therapy. Clinic visit and quality of life scale questionnaires will be recorded at 3 and 12 months and echocardiography will be assessed at 3 months. Graft patency at 12 months will be assessed with a CT coronary angiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with multi-vessel coronary artery disease (MVCAD) | iFR measurements will be taken pre-operatively during the invasive coronary angiography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary artery bypass grafting surgery (CABG) | Procedure | Patients with MVCAD will undergo CABG as per standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Graft patency | The primary endpoint will be graft patency as assessed by CT coronary angiography at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Questionnaire | Patient's view in their quality of life | 3 and 12 months |
| Composite of MACE (MI, Death, stroke, repeat revascularisation) | Assessed by the presentation of clinical symptoms and echocardiography during a follow-up visit at 3 months or anytime within 12 months. |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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Retrospective cohort study - approximately 250 pts Prospective cohort study - minimum 28 pts - maximum 100 pts
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP | Contact | 020 3313 2026 | +44 | P.Punjabi@imperial.ac.uk |
| Panagiotis G Kyriazis, BSc, MRes | Contact | 020 3313 2026 | +44 | Panagiotis.Kyriazis@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust - Hammersmith Hospital | Recruiting | London | Greater London | W12 0HS | United Kingdom |
Anonymised individual participant data for all primary and secondary outcome measures will be made available.
36 months
According to study protocol
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 12 months |
| Any episode of reintervention | Patient undergoing repeat reintervention | 12 months |
| Incidence of Myocardial infarction | Assessed by the presentation of clinical symptoms, echocardiography during a follow-up visit at 3 months or anytime within 12 months and in addition, evidence of percutaneous or surgical revascularisation within the last 12 months. | 12 months |
| Incidence of Stroke | Assessed by the presentation of clinical symptoms during a follow-up visit at 3 and 12 months or anytime within 12 months. | 12 months |
| Left ventricular function at 3 months with an echocardiography | Cardiac functional assessment at 3 months post-opereatively | 3 months |
| Incidence of Death (all-cause) | Patient deceased | 12 months |
| Incident of Death (cardiovascular) | Patient deceased | 12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |