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

NCT02384824 | Unknown

• 1 other identifier: SAHZJU CT003
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Coronary Artery Disease; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• plaque morphology by OCT

  at the 7th day post PCI/aspiration thrombectomy

Secondary Outcomes (2)

• Re-hospitalization due to cardiac symptoms

  30 days & 12 months

• Myocardial infarction related to the target vessel

  30 days & 12 months

Interventions

Primary Percutaneous Intervention PROCEDURE

angiography, manual aspiration thrombectomy and antiplatelet therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with acute STEMI

You may qualify if:

• 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
• 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

You may not qualify if:

• Contraindicating to any concomitant study medications
• Having cardiogenic shock with hemodynamic instability
• A history of bleeding diathesis or known coagulopathy
• 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
• Planned surgery which may cause discontinuation of ADP-receptor antagonist
• Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year
• Repeated MI within 7 days of hospitalization for acute MI
• 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

Sponsors & Collaborators

• Jian'an Wang,MD,PhD: lead

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: March 10, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 10, 2015

Record last verified: 2015-03