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Status unknownNCT02384824STEMI-OCTUpdated Mar 10, 2015

Delayed Plaque Morphology in Patients With STEMI After Thrombus Aspiration During Primary PCI

An observational study in Coronary Artery Disease and Myocardial Infarction, sponsored by Jian'an Wang,MD,PhD. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-10.

Sponsored by Jian'an Wang,MD,PhD · Observational

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to characterize the plaque morphology in patients with acute STEMI by OCT after aspiration thrombectomy.

Read the detailed description

Current guideline for treating acute STEMI is primarily PCI and stent placement in the infarct-related coronary artery. But, the underlying plaque morphology is not routinely identified due to the limited resolution of conventional imagine modalities. However, autopsy studies have shown that there are different atherosclerotic plaque morphologies involving in acute thrombotic occlusion of coronary arteries other than atherosclerotic plaque rupture, such as plaque erosion, calcified nodule, etc. Some studies have suggested that PCI and stenting might not always be necessary in about 30 - 40% of ACS patients, and an alternative treatment strategy is needed for these patients based on the characteristics of plaque morphology.

100 subjects who meet the inclusion/exclusion criteria will undergo emergent angiography and followings: If no thrombus was observed, OCT examination will be performed in the target vessel;

If thrombosis was confirmed, the subject will undergo manual aspiration thrombectomy and antiplatelet therapy, and TIMI flow will be assessed:

If TIMI flow grade \< 3, the subject will receive stent implantation as the standard of care followed by OCT examination; If TIMI flow grade of 3, the subject will not receive stent implantation but will be sent to CCU for monitoring and antiplatelet treatment, and have a repeat angiography and OCT examination at Day 7; within the 7days post STEMI, ischemia-driven angiography and/or PCI are allowed, and an OCT examination will be performed in these subject before PCI.

Patients without undergoing initial stent implantation will have scheduled 30-day and 12-month follow-ups for clinical outcomes.

02

Conditions studied

  • Coronary Artery Disease
  • Myocardial Infarction
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 100 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Jian'an Wang,MD,PhD is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with acute STEMI

Inclusion criteria

  1. Clinical inclusion criteria:

    • Age > 18 years
    • Onset of STEMI > 30 minutes, but \< 12 hours
    • ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG
    • Willing and able to provide informed consent

  2. Angiographic inclusion criteria:

    • Having at least one infarct-related coronary artery, of which
    • The Culprit lesion is suitable for stenting;
    • The reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm;
    • The TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing
    • No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation

Exclusion criteria

Exclusion Criteria:

  1. Clinical exclusion criteria:
  1. Contraindicating to any concomitant study medications
  2. Having cardiogenic shock with hemodynamic instability
  3. A history of bleeding diathesis or known coagulopathy
  4. A history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count \< 100,000 /mm3 or Hb \< 10 g/dL
  5. Planned surgery which may cause discontinuation of ADP-receptor antagonist
  6. Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year

  7. Repeated MI within 7 days of hospitalization for acute MI

    • Angiographic exclusion criteria:

      • Bifurcated lesion unable to identify the culprit lesion
      • The culprit lesion is located in the left main artery
      • Diffusive lesions without distinguishable culprit lesion
      • Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis
      • Likely CABG procedure within 30 days
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • ProcedurePrimary Percutaneous Intervention

    angiography, manual aspiration thrombectomy and antiplatelet therapy

06

What researchers measure

Primary outcomes

  1. plaque morphology by OCT

    Time frame: at the 7th day post PCI/aspiration thrombectomy

Secondary outcomes

  1. Re-hospitalization due to cardiac symptoms

    Time frame: 30 days & 12 months

  2. Myocardial infarction related to the target vessel

    Time frame: 30 days & 12 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02384824
Lead sponsor
Jian'an Wang,MD,PhD
Responsible party
Jian'an Wang,MD,PhD (President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University) — Sponsor-investigator
First posted
Mar 10, 2015
Start date
Apr 2015
Primary completion
Apr 2017 (estimated)
Completion
Oct 2017 (estimated)
Last update
Mar 10, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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