Dept. of Cardiology, Oslo Univ. Hosp. Ulleval
Oslo, N-0407, Norway
NCT Number: NCT00922675
Study objectives: To assess the effects of postconditioning on infarct size in patients with ST-elevation infarction referred to PCI.
Study design: Prospective, randomized, open-label study with blinded endpoint evaluation. Included patients will be randomly allocated to postconditioning or control. Patients with symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ECG criteria for primary PCI are eligible. PCI follow established routines. In postconditioning patients, additional, short (1 min), intermittent balloon occlusions will be applied after initial opening of infarct related artery. After this intervention, PCI proceeds routinely with stent implantation. In the control group, stent implantation after initial opening proceeds as usual. Primary endpoint is final infarct size, determined by MRI after 4 months. 260 patients will be included. Follow-up is 1 year. Inclusion period: 18 - 24 months.
Clinical implications: Reperfusion therapy, administered as early as possible after start of symptoms, has improved the prognosis in acute ST-elevation myocardial infarction. Still, however, many patients suffer large infarctions, subsequently with an increased risk of heart failure, arrhythmias, and death. In pilot studies, mechanical postconditioning has been shown to reduce infarct size and thus potentially improve prognosis. However, the effect of postconditioning must be confirmed in larger clinical trials before implemented in routine treatment.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Oslo, N-0407, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting. In the postconditioning group 4 additional balloon inflations separated by 1 minute reperfusion are given, starting after 1 minute of reperfusion.
After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.
Time frame: 4 months
Time frame: assessed at the end of PCI procedure
Time frame: Assessed after 1 hour
Time frame: peak release values
Time frame: assessed at baseline, 4 months and1 year
Assesment of LV function. Comparison with CMR in the whole study population and between treatment groups.
Time frame: 1-year follow up.
Time frame: Baseline to 4 months
Myocardial salvage defined as (area at risk-final infarct size)/area at risk. Area at risk measured by CMR at baseline and final infarct size by CMR at 4 months.
Oslo University Hospital
Other
Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI
Acronym: POSTEMI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03677466
Arterial Occlusive Diseases, Arteriosclerosis
Tomsk, Russia
View Trial DetailsNCT06065514
Angina Pectoris, Angina, Unstable
Nicosia, Cyprus
View Trial DetailsNCT07519590
Arterial Occlusive Diseases, Arteriosclerosis
Cairo, Cairo Governorate, Egypt
View Trial DetailsNCT05844566
Acute Coronary Syndrome, Cardiovascular Diseases
Bologna, Italy
View Trial Details