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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Simon
Hindley
s.hindley@nhs.net
Maria
Vourvou
maria.vourvou@nhs.net
Prof
Anthony
Mathur
a.mathur@qmul.ac.uk
Maria
Vourvou
maria.vourvou@nhs.net
Ischaemic heart diseases
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Due to improvements in medical therapies and revascularisation strategies,more people with coronary artery disease are surviving but living with chronic debilitating symptoms called Refractory angina (RFA). The management of angina remains challenging using conventional treatment strategies; a significant number of patients remain symptomatic despite PCI,CABG and anti-anginal drugs.
In the UK,the management of patients with RFA is underprovided. The national provision of specialist care is limited with major geographical inequality in access to dedicated RFA services. Patients commonly end up in a perpetual and frequent cycle of long-term local review alternating between the outpatient and the A&E department and poses an economic burden. In this trial,we will investigate whether cell therapy will improve the blood flow to the heart and relieve the symptoms of angina. The cells harvested from patients’ own bone marrow are not yet ‘specialised’ and so have the potential to become any type of cell. These stem cells are infused into the heart arteries with the aim of improving the heart’s blood supply and the symptoms of refractory angina. 110 patients.
will be recruited over 18 months. Half of the patients will have cell therapy whilst the other half will undergo a sham procedure. All
patients will be treated at Barts Heart Centre and will be followed up at 1 week,6months and 12 months after their treatment.
Patients will not be aware of what treatment they have received until after the study has been completed.
Eligible patients will undergo a screening visit to confirm they meet all inclusion criteria and collect baseline angina score,quality of
life,total exercise time and myocardial perfusion information. This assessment will be repeated at 6 and 12 months to assess
whether the cell therapy leads to an improvement in angina symptoms and quality of life.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Cellular;Complex Intervention;
You can take part if:
You may not be able to take part if:
Exclusion Criteria: 1. Recent (within 30 days prior to enrolment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI). 2. Recent successful revascularisation by CABG or PCI within six months prior to enrolment 3. Recent unsuccessful PCI (e.g.,no relief from symptoms,failed attempt to open a chronic total occlusion) within 30 days prior to enrolment 4. The predominant manifestation of angina is dyspnoea 5. Has extra-coronary contributory causes of angina - e.g.,untreated hyperthyroidism,anaemia (hgb <10 g/dL),uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg despite medications),atrial fibrillation with rapid ventricular response (consistently >100 bpm despite medications) or other tachyarrhythmia,severe aortic stenosis,hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric left ventricular hypertrophy is not an exclusion criterion),etc. 6. NYHA Class III or IV heart failure (HF),decompensated HF or hospitalisation due to HF during the 90 days prior to enrolment 7. Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and/or pacemaker 8. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second (FEV1) that is less than 55% of the predicted value,or need for home daytime oxygen or oral steroids 9. Severe valvular heart disease (any valve) 10. Moderate or severe RV dysfunction by echocardiography (as assessed by Investigator) 11. Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula) 12. Any clinical condition that might interfere with the trial protocol or the subject's ability to be compliant with the trial protocol (e.g.,active alcohol or drug abuse,dementia,etc.) 13. Currently enrolled in another investigational device or drug trial that has not reached its primary endpoint or that might clinically interfere with the current trial endpoints or procedures 14. Pregnant or planning pregnancy within the next 12 months (women of reproductive potential must have a negative pregnancy test within 7 days of the randomisation procedure)* 15. Subject is part of a vulnerable population who,in the judgment of the investigator,is unable to give Informed Consent for reasons of incapacity,immaturity,adverse personal circumstances or lack of autonomy. This may include individuals with mental disability,persons in nursing homes,children,impoverished persons,persons in emergency situations,homeless persons,nomads,refugees,and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students,subordinate hospital and laboratory personnel,employees of the Sponsor,members of the armed forces,and persons kept in detention. 16. Inability to tolerate dual antiplatelet therapy for 1 month if not on a chronic oral anticoagulant,or inability to tolerate a P2Y12 inhibitor for at least 1 month if on a chronic oral anticoagulant 17. Comorbidities limiting life expectancy to less than one year if recorded in patient’s notes 18. Documented acute infection in patient’s notes 19. Immunosuppressive medication 20. Inability to understand verbal and written English 21. No evidence of reversible ischaemia on a PET/SPECT scan perfusion scan in last 24 months of consent (subject to Investigator’s discretion)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Anthony
Mathur
a.mathur@qmul.ac.uk
Maria
Vourvou
maria.vourvou@nhs.net
Maria
Vourvou
maria.vourvou@nhs.net
Simon
Hindley
s.hindley@nhs.net
The study is sponsored by BARTS HEALTH NHS TRUST and funded by BARTS CHARITY; CVCL Foundation for Research and Development in Cardiovascular Medicine; .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 63241
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