NCT03062826

Brief Summary

This protocol describes a prospective, multi-center study intended to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis \<70%) can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI) with stent implantation. All the patients will be followed by intracoronary OCT and physiological assessment at 1-month and 12-month follow-up.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

5.1 years

First QC Date

February 20, 2017

Last Update Submit

June 23, 2022

Conditions

ST-segment Elevation Myocardial Infarction

Keywords

Optical Coherence TomographyST-segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Reduction of thrombus burden assessed by OCT

    The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month.

    30 days

Secondary Outcomes (4)

  • Major cardiovascular adverse events

    1, 3, 6, 9, 12 months after PCI

  • Major cardiovascular adverse events

    1 and 12 months after PCI

  • Effective flow area increase

    1 and 12 months after PCI

  • Fractional flow reserve

    1 and 12 months after PCI

Study Arms (1)

Patients with STEMI treated medically

Drug: dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel) for at least 12 months.

Drug: dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel)

Interventions

dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel)DRUG

Patients who met the inclusion criteria will be treated with dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel).

Patients with STEMI treated medically

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population is STEMI patients who undergo primary cardiac catheterization.

You may qualify if:

  • Men or non-pregnant women \>18 years of age and \< 75 years of age.
  • Patients undergo cardiac catheterization for STEMI. STEMI will be defined as continuous chest pain for \>30 minutes, arrival at the hospital within 24 hours from chest pain onset, ST-segment elevation \>0.1 mV in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ECG), and elevated cardiac markers (troponin T/I or creatine kinase-MB).
  • Culprit lesion located in a native coronary artery.
  • TIMI flow grade 3 and diameter stenosis \< 70% by visual assessment on angiogram or MLA \> 1.6mm2.
  • Plaque erosion and rupture defined by OCT.
  • Patients able to provide written informed consent.

You may not qualify if:

  • Left ventricular ejection fraction \< 30%.
  • Lesions in LM, ostial LAD or RCA (defined as within 3 mm of the aorto-ostium).
  • Long lesions, tortuous lesions and angulated lesions.
  • More than 2 vessels with severe lesions.
  • Massive residual thrombus after the thrombus aspiration.
  • With the history of cardiopulmonary resuscitation (CPR), acute pulmonary edema and cardiac shock on the attacks.
  • Life expectancy \< 1 year.
  • Contraindication to the contrast media.
  • Creatinine level \> 2.0 mg/dL or end-stage kidney disease.
  • Serious liver dysfunction.
  • Patients with hemodynamic or electrical instability (including shock).
  • Any contraindication against the use of ticagrelor.
  • Investigator considers the patient is not suitable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Beijing Luhe Hospital

Beijing, Beijing Municipality, 101100, China

Location

Xiamen Cardiovascular Hospital, Xiamen University

Xiamen, Fujian, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

Shenzhen Sun Yat-sen Cardiovascular Hospital

Shenzhen, Guangzhou, China

Location

Hebei General Hospital

Shijiazhuang, Hebei, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Location

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Location

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Shenyang, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample will be obtained from artery sheath or coronary artery by aspiration catheter during the PCI procedure in selected sites, and will be stored at -80°C.

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

AspirinTicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Bo YU, MD, PhD

    The Second Affiliated Hospital of Harbin Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 20, 2017

First Posted

February 23, 2017

Study Start

January 11, 2017

Primary Completion

February 24, 2022

Study Completion

March 1, 2023

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
2020

Locations

CN(16)