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Health Condition(s) or Problem
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Myocardial Infarction (STEMI / NSTEMI) and Diabetes mellitus (DM)
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Lay Summary
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Lay summary under review 3 (from ISRCTN)
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Who can enter the trial
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A participant may enter the study if ALL of the following apply:
1. Presentation to a Bristol Heart Institute cardiologist within 24 hours after the onset of symptoms
2. Admission with STEMI or NSTEMI (troponin positive acute coronary syndromes)
3. Aged 40 to 75 at admission
4. Reside within 40 miles of the Bristol Royal Infirmary
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Who cannot enter the trial
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A participant may not enter study if ANY of the following apply:
1. Anaemia, i.e. haemoglobin <10mg/dl
2. Cardiogenic shock on presentation
3. Renal impairment [Glomerular filtration rate (GfR) <50ml]
4. Haemodynamic instability
5. Contraindications to having the MRI scan (e.g. metallic implant, pacemakers, screws, claustrophobia, etc)
6. Previous coronary event within the last 12 weeks
7. Participation in another clinical study
8. Patients who are unable or unwilling to return for follow-up in accordance with the study schedule on day 4, or after three months
9. Heightened anxiety during recruitment
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What will happen
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In order to characterise the response of CPCs, blood samples are taken on day 0 (up to 24hrs after patient?s presentation of symptoms) and day 4. MRI scans are performed at baseline (day 4) and three months after patients? presentation of symptoms. Involvement in the study concludes 12 months after the index event, when the participant will be contacted by telephone to ascertain any adverse events, hospital admissions or changes to medication occurring since the index admission.
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Primary aim
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1. For objective 1 - the number of CPCs measured in a peripheral blood sample or the migratory ability of CPCs expressing CXCR4 to the chemo-attractant stromal cell-derived factor-1 (SDF-1) (assessed in a test tube by a migration assay).
2. For objective 2 - the size of myocardial scar (volume or mass of affected myocardium) three months after symptom onset
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Secondary Aim
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1. For objective 1:
1.1. Number of CPCs expressing cell surface markers: CD34, CD133, c-kit, KDR, trkA, beta-2, CD14 and CD16, either viable, apoptotic or necrotic
1.2. Migratory ability of Peripheral Blood Mononuclear Cell Culture (PBMNC) expressing CPC surface markers: CD34, CD133, c-kit, KDR, trkA, beta-2, CD164, CD14, CD16. For migration assays, we will use SDF-1 and Nerve growth factor (NGF) as chemo-attractants and PBS as vehicle control
1.3. Viability of CPCs on Day 4 for CPCs expressing CXCR4 and sub-populations of CPCs expressing cell surface markers: CD34, CD133, c-kit, KDR, trkA, beta-2, CD164, CD14 and CD16)
2. For objective 2:
2.1. Myocardial contractility / wall thickening three months after the index STEMI or NSTEMI
2.2. Left ventricular (LV) wall motion
3. The following clinical outcomes will be evaluated at day 4, 3 and 12 months after the index admission:
3.1. Incidence of peri-procedural myocardial damage, assessed by analysis of creatinine kinase
3.2. Major adverse cardiac-related events (death, new MI, further revascularisation, recurrent angina as defined by repeat coronary angiogram for chest pain symptoms)
3.3. Hospitalisation rates
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Participant Information Sheet
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Not available in web format, please use the contact details below to request a patient information sheet
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Bristol
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