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OpenTrials
Completed

NCT Number: NCT01384019

Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)

The investigators examined the mechanism underlying the lack of benefit from distal protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial Infarction (STEMI) in a prospective, randomized trial.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul Natioinal University Bundang Hospital

Seongnam, South Korea

About this study

Patients with first-diagnosed STEMI were randomly assigned to distal protection and thrombus aspiration (DP-TA) pretreatment during percutaneous coronary intervention (PCI) or conventional PCI (c-PCI).

The primary endpoint was the remodeling index (RI), measured by cardiac magnetic resonance imaging (CMR) post-PCI and 6 months after PCI.

Secondary endpoints, determined by CMR within 3 to 5 days after PCI, included the infarct ratio (infarct size to entire left ventricular [LV] size ) by delayed-enhancement (DE), area at risk (AAR) ratio (AAR to LV size) by T2 high-signal intensity , microvascular occlusion index (MVO) ratio (MVO to LV size) by DE, and myocardial salvage index (MSI, [AAR-infarct size] x 100/AAR).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 30 and less than 80 years presenting with STEMI
  • more than 30 minutes but less than 12 hours after symptom onset
  • with ≥ 2 mm of ST-segment elevation in 2 or more contiguous leads or with a presumably new left bundle-branch block
  • for whom primary PCI was intended

Exclusion criteria

  • included thrombolytic therapy before PCI;
  • spontaneous restoration of coronary flow (> TIMI grade II or III);
  • cardiogenic shock (Killip class IV);
  • major surgery or active bleeding within 6 weeks;
  • aspirin, thienopyridine, or heparin allergy;
  • neutropenia (<1000 neutrophils/mm3), thrombocytopenia (<100000 platelets/mm3), hepatic dysfunction, or renal insufficiency (serum creatinine level >2.5 mg/dL [221 μmol/L]);
  • noncardiac condition with expected survival less than 1 year;
  • current participation in other investigations.

Treatment and study plan

distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))

Device

The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration

Other names: The GuardWire Plus (Medtronic Inc.)

c-PCI

Procedure

conventional PCI without Guard wire

Other names: convenional PCI

Primary outcomes

  1. Postinfarct Remodeling

    Time frame: 6 months

    postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI

Secondary outcomes

  1. Reperfusion Success

    Time frame: 3-5 days

    microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Distal Protection Device Did Not Improve Microvascular Obstruction Evaluated by Cardiac MR After Primary Percutaneous Intervention for ST-elevation Myocardial Infarction

Important dates

Study start
2004
Primary completion
2008
Study completion
2011
First posted
Jun 28, 2011
Registry last updated
Mar 18, 2013

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.

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