ST-segment Elevation Myocardial InfarctionPhase 4NCT01384019

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

A Phase 4 study testing distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.)) and c-PCI in people with ST-segment Elevation Myocardial Infarction, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 30 to 80 years
Conditions the study is for: ST-segment Elevation Myocardial Infarction
What is being tested?: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.)) and c-PCI
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 126 participants
Where: 1 siteSouth Korea
Study dates: Jan 2004to Aug 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul Natioinal University Bundang Hospital
Seongnam

Other trials in South Korea

About this study

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

Read the detailed description

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).

Conditions: ST-segment Elevation Myocardial Infarction
Being tested: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.)), c-PCI
Keywords: ST-elevation myocardial infarction, percutaneous coronary intervention, cardiac magnetic resonance imaging, microvascular occlusion, myocardial salvage
Medical subject headings: ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))Device
Also called The GuardWire Plus (Medtronic Inc.)
The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration
c-PCIProcedure or surgery
Also called convenional PCI
conventional PCI without Guard wire

Study groups in NCT01384019
Study group	Role	What they receive
DP-TA	Experimental	distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) Receives: Device: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))
c-PCI	Placebo comparator	conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction Receives: Procedure: c-PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Reperfusion Success
microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR
Measured: 3-5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2004Aug 2011

First posted28 Jun 2011 (estimated)
Study startJan 2004
Primary completionJun 2008
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01384019
Sponsor's protocol ID: SNUBH-001
Status last verified: Feb 2013
First submitted: 27 Jun 2011
Last updated: 18 Mar 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
Integrated Assessment, Immune-Inflammatory
Enrolling by invitationObservational study
Metabolic Characteristics of Plasma OxPLs in STEMI Patients.
STEMI - ST-segment Elevation Myocardial Infarction
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
Recruiting
The FAVOR V AMI Trial
ST-Segment Elevation Myocardial Infarction, Multivessel Coronary Artery Disease
Active, not recruiting
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI

All ST-segment Elevation Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Distal Protection Device Did Not Improve Microvascular Obstruction Evaluated by Cardiac MR After Primary Percutaneous Intervention for ST-elevation Myocardial Infarction
ClinicalTrials.gov ID: NCT01384019
Acronym / sponsor ID: SNUBH-001
Conditions: ST-segment Elevation Myocardial Infarction
Keywords: ST-elevation myocardial infarction, percutaneous coronary intervention, cardiac magnetic resonance imaging, microvascular occlusion, myocardial salvage
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Seoul National University Bundang HospitalUniversity, hospital or other
Study start: Jan 2004
Primary completion: Jun 2008 (actual)
Study completion: Aug 2011 (actual)
First posted: 28 Jun 2011 (estimated)
Results: Posted 18 Mar 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
DP-TA	Experimental	Device: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
c-PCI	Placebo comparator	Procedure: c-PCIconventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))Also: The GuardWire Plus (Medtronic Inc.)The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration	Device	DP-TA
c-PCIAlso: convenional PCIconventional PCI without Guard wire	Procedure or surgery	c-PCI

Primary outcome

Postinfarct Remodeling
Time frame: 6 months
postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI

1 secondary outcome

Reperfusion Success
Time frame: 3-5 days

Results and safety

Results posted to the registry on 18 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DP-TA	65	55
c-PCI	61	55

Primary outcome: Postinfarct Remodeling

Time frame: 6 months. Number. Unit: Number of participants with remodeling

Measure	DP-TA n = 41	c-PCI n = 43
Value	11	6

Population analysed: Forty one patients underwent 6 month CMR in distal protection group and 43 patients, in conventional PCI group.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DP-TA	7 of 65 (10.8%)	0 of 65 (0%)	Not reported
c-PCI	7 of 61 (11.5%)	0 of 61 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for ST-segment Elevation Myocardial Infarction

RecruitingObservational study
Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
Integrated Assessment, Immune-Inflammatory
Enrolling by invitationObservational study
Metabolic Characteristics of Plasma OxPLs in STEMI Patients.
STEMI - ST-segment Elevation Myocardial Infarction
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
Recruiting
The FAVOR V AMI Trial
ST-Segment Elevation Myocardial Infarction, Multivessel Coronary Artery Disease
Active, not recruiting
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dong-ju Choi, MD principal investigator

Seoul National University Bundang Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postinfarct Remodeling (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01384019.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2013; AzTrials last refreshed its copy on 1 Nov 2026.