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Table 2 A priori defined secondary and tertiary outcome measures

From: Assessment of safety and efficacy of mesenchymal stromal cell therapy in preclinical models of acute myocardial infarction: a systematic review protocol

Outcomes

Comments and/or Examples of specific measures

Secondary outcomes:

 Death

Rarely used an outcome due to ethical concerns regarding animal welfare

 Infarct size

Variety of quantifiable techniques (e.g. histological staining, nuclear imaging)

 Cardiac function

Echocardiography

â—¦ cardiac output

â—¦ left ventricle end diastolic diameter

â—¦ left ventricle end systolic diameter

â—¦ fractional shortening

Cardiac catheterization

â—¦ cardiac output

â—¦ left ventricular end diastolic pressure

â—¦ left ventricular end systolic pressure

â—¦ mean pulmonary artery pressure

â—¦ right atrial pressure

 Biochemical outcomes

Proinflammatory cytokines

â—¦ interleukin-1beta, 6

â—¦ tumour necrosis factor-alpha

Anti-inflammatory cytokines

â—¦ interleukin-10

â—¦ transforming growth factor-beta1, 2, 3

 Vessel density

Histological staining and quantification of vessels in cardiac tissue

Tertiary outcomes:

 Cellular retention

Imaging and quantification of labelled cells in host tissue

 Cellular differentiation

Measurement of cardiac troponin in donor cells retained in host tissue