Progenitor cell response following Myocardial Infarction Study (ProMIS)

Not Applicable

Completed

Conditions: Myocardial infarction (STEMI/NSTEMI) and diabetes mellitus (DM)
Circulatory System
Acute myocardial infarction

Registration Number: ISRCTN19569306

Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>2. For objective 2 - the size of myocardial scar (volume or mass of affected myocardium) three months after symptom onset

Secondary Outcome Measures