Huang 2006.
Methods |
Type of study: parallel RCT
Type of publication: full
Source of funding: not reported Country of origin: China Number of centres: 1 (assumed) Dates of trial enrolment: 05/04 to 05/05 Length of follow‐up: 6 months Number (N) of participants randomised to each arm: 20 in treatment arm/20 in control arm Number (N) of participants analysed (primary outcome) in each arm: 20 in treatment arm/20 in control arm |
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Participants |
Population: AMI, within 24 hours. PCI within 24 hours. Cell transplantation within 2 hours of successful PCI
Age, mean (SD) each arm: 57.3 (10.1) years in treatment arm, 56.7 (9.2) years in control arm
Sex, % male in each arm: 65% in treatment arm, 70% in control arm Number of diseased vessels: not reported Number of stunned hyperkinetic, etc segments: not reported Time from symptom onset to initial treatment: 6.3 (4.2) hours in treatment arm/6.3 (3.9) hours in control arm Statistically significant baseline imbalances between the groups?: none |
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Interventions |
Intervention arm: BMSC
Type of stem cells: bone marrow‐derived stem cells (mononuclear cells‐MNC)
Summary of how stem cells were isolated and type and route of delivery: bone marrow aspirate (80 to 140 mL). Cells separated by gradient centrifugation. Cells re‐suspended in heparinised saline (with 0.9% NaCl) prior to transplantation. Intracoronary infusion using a microcatheter (Judkins method)
Dose of stem cells: a single dose of 1.8 (4.2) x108/mL cells
Timing of stem cell procedure: cells infused within 2 hours of successful PCI Comparator arm: 15 mL of heparinised saline (with 0.9% NaCl) |
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Outcomes | Primary outcomes: not reported Secondary outcomes: LVEF, LVEDV and infarct size measured by CMR imaging and LV arteriography Outcome assessment points: baseline, 1 week and 6 months Method(s): CMR imaging | |
Notes | Translated from Chinese (Mandarin) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | This Chinese trial was described as randomised but the method of randomisation was not reported |
Allocation concealment (selection bias) | High risk | Allocation concealment was not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | The control group received a placebo but it was unclear whether they underwent bone marrow aspiration and therefore it was unclear whether they were appropriately blinded. Blinding of clinicians and outcome assessors was not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants were included in the analysis of clinical and scientific outcomes |
Selective reporting (reporting bias) | Unclear risk | All outcomes mentioned in the methods were reported in the results, although it would be difficult to rule out selective reporting |
Other bias | Low risk | None reported or identified |