Clinical trial NCT00675480: Thrombectomy in Acute Myocardial Infarction
Official title: Aspiration Thrombectomy as an Adjunctive Therapy to Primary Angioplasty in Patients With ST Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myocardial Infarction
Keywords: myocardial infarction, thrombectomy, salvage index
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2008-05-09
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether thrombus removal with aspiration thrombectomy for acute myocardial infarction reduces the infarct size.

Detailed description: Acute myocardial infarction is caused by an abrupt occlusion of coronary vessel or severe reduction of coronary flow. It has been shown that the reperfusion therapy significantly improves the clinical outcome. Currently the optimal strategy is the primary angioplasty with stent implantation. The treatment is recommended by AHA/ACC and ESC if can be performed within 90 minutes from the first medical contact. However there is still a certain percentage of procedure failure. To further improve the outcome new techniques and devices are tested . Aspiration thrombectomy may facilitate the reperfusion by reducing thrombus burden. The aim of the study is to assess if adjunctive thrombectomy may improve clinical outcome in patients with an acute ST segment elevation myocardial infarction.

Eligibility criteria: Inclusion Criteria:

1. First acute myocardial infarction with ST segment elevation within 12 hours from pain onset
2. Culprit lesion in left anterior descending or right coronary artery.
3. Coronary flow assessed in TIMI scale ≤ 2
4. Presence of total coronary occlusion or angiographically visible thrombus in the culprit vessel
5. Patient signed informed consent

Exclusion Criteria:

1. Cardiogenic shock.
2. Culprit lesion in left circumflex coronary artery.
3. Status post coronary artery by-pass grafting
4. Previous myocardial infarction
5. Status post percutaneous coronary intervention.

Primary outcomes:
measure: Myocardial salvage index assessed with SPECT MIBI.
timeFrame: 5-8 days
Secondary outcomes:
measure: In hospital mortality
timeFrame: in hospital, before discharge
measure: ST segment resolution after PCI;
timeFrame: 90 minutes
measure: CK-MB AUC
timeFrame: 72 hours
measure: Corrected TIMI frame count
timeFrame: immediately post PCI
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Michal Ciszewski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ciszewski M, Pregowski J, Teresinska A, Karcz M, Kalinczuk L, Pracon R, Witkowski A, Ruzyllo W. Aspiration coronary thrombectomy for acute myocardial infarction increases myocardial salvage: single center randomized study. Catheter Cardiovasc Interv. 2011 Oct 1;78(4):523-31. doi: 10.1002/ccd.22933. Epub 2011 Jun 6.