Table 2.
IMPACT criteria for the in vivo preclinical evaluation of efficacy and performance of novel cardioprotective interventions
| Step 1: IMPACT criteria for validation in healthy small animal models |
| Minimum criteria: |
| Validation in one species (e.g.: mouse, rat or rabbit) |
| Validation in a single centre |
| Acute IRI model (minimum of 2 h and preferably 24 h of reperfusion) |
| Infarct size relative to area-at-risk and possibly also coronary microvascular obstruction |
| Desirable criteria: |
| Validation in 2 different species/strains |
| Chronic IRI model (at least 28 days of reperfusion) |
| Infarct size and LV remodelling (at least 28 days of reperfusion) |
| Step 1a: IMPACT criteria for multicentre validation in healthy small animal models |
| Minimum criteria: |
| Validation in at least one species |
| Validation in at least 3 centres |
| Acute IRI model (minimum of 2 h and preferably 24 h of reperfusion) |
| Infarct size and possibly also coronary microvascular obstruction |
| Desirable criteria: |
| Validation in 2 different species/strains |
| Chronic IRI model (at least 28 days of reperfusion) |
| Infarct size and LV remodelling (at least 28 days post-infarction) |
| Step 2: IMPACT criteria for validation in small animal models with confounders |
| Minimum criteria: |
| Validation in the presence of at least one confounder (e.g. age, diabetes mellitus, P2Y12 inhibitor) |
| Acute IRI model (minimum of 2 h and preferably 24 h of reperfusion) |
| Infarct size and possibly also coronary microvascular obstruction |
| Desirable criteria: |
| Validation in both male and female animals |
| Validation in the presence of two or more confounders |
| Chronic IRI model (at least 28 days of post-infarction) |
| Infarct size and LV remodelling (at least 28 days post-infarction) |
| Step 3: IMPACT criteria for validation in large animal models |
| Minimum criteria: |
| Validation in one species (e.g.: pig) |
| Validation in a single centre |
| Acute IRI model (minimum of 2 h and preferably 72 h of reperfusion) |
| Infarct size and possibly also coronary microvascular obstruction |
| Desirable criteria: |
| Validation in both male and female animals |
| Chronic IRI model (at least 3 months post-infarction) |
| Infarct size and LV remodelling (at least 3 months post-infarction) |
| Assessment in animals with a co-morbidity |
| Step 3a: IMPACT criteria for multicentre validation in large animal models |
| Minimum criteria: |
| Validation in at least 3 centres |
| Acute IRI model (minimum of 2 h and preferably 72 h of reperfusion) |
| Infarct size and possibly also coronary microvascular obstruction |
|
Desirable criteria: Validation in 2 different species/strains Chronic IRI model (at least 3 months post-infarction) Infarct size and LV remodelling (at least 3 months post-infarction) |