NCT05007535

Brief Summary

This prospective, single arm, observational cohort study is designed to assess the safety and efficacy of (high-definition) intravascular ultrasound (HD-IVUS) as guidance for primary percutaneous coronary intervention (PCI) and to assess culprit lesion plaque characteristics and thrombus morphology in patients with ST-elevation myocardial infarction (STEMI). Objectives:

  • To assess clinical outcomes after IVUS-guided primary PCI in STEMI patients.
  • To assess IVUS-guided optimization in STEMI patients.
  • To assess culprit lesion plaque characteristics in STEMI patients with HD-IVUS.
  • To assess and quantify thrombus in STEMI patients with HD-IVUS.
  • To explore HD-IVUS derived predictors for clinically relevant aspiration thrombectomy.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

November 10, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

April 21, 2021

Last Update Submit

January 16, 2023

Conditions

ST Elevation Myocardial InfarctionAcute Myocardial InfarctionCoronary Artery DiseasePercutaneous Coronary InterventionIntravascular UltrasoundThrombus

Keywords

Invasive Coronary Imaging

Outcome Measures

Primary Outcomes (2)

  • Target Vessel Failure (TVF)

    A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization

    12 Months

  • IVUS-guided optimization

    Incidence of IVUS-guided additional balloon dilatation or stent placement after angiographically successful PCI

    Procedural

Secondary Outcomes (9)

  • TVF

    30 Days

  • Major Adverse Cardiovascular Events (MACE)

    30 Days

  • Major Adverse Cardiovascular Events (MACE)

    12 Months

  • Individual Components of TVF and MACE

    30 Days

  • Individual Components of TVF and MACE

    12 months

  • +4 more secondary outcomes

Study Arms (1)

HD-IVUS-guided primary PCI

Prospective, single arm, observational

Eligibility Criteria

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

Patients presenting with ST-elevation myocardial infarction eligible for primary percutaneous coronary intervention.

You may qualify if:

  • Native coronary artery culprit lesion, angiographically
  • Culprit vessel reference diameter ≥ 2.25 mm, angiographically

You may not qualify if:

  • Cardiogenic shock
  • Presentation \> 12 hours after symptom onset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus University Medical Center

Rotterdam, 3015GD, Netherlands

Location

Related Publications (2)

  • Groenland FTW, Ziedses des Plantes AC, Neleman T, Scoccia A, Ligthart JMR, Witberg KT, Mahmoud KD, Nuis RJ, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Van Mieghem NM, Daemen J. Culprit lesion plaque characterization and thrombus grading by high-definition intravascular ultrasound in patients with ST-segment elevation myocardial infarction. Catheter Cardiovasc Interv. 2023 Aug;102(2):191-199. doi: 10.1002/ccd.30699. Epub 2023 May 26.

    PMID: 37232425DERIVED

  • Groenland FTW, Mahmoud KD, Neleman T, Ziedses des Plantes AC, Scoccia A, Ligthart J, Witberg KT, Nuis RJ, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Kardys I, Cummins P, Van Mieghem NM, Daemen J. Tissue characterisation and primary percutaneous coronary intervention guidance using intravascular ultrasound: rationale and design of the SPECTRUM study. Open Heart. 2022 Apr;9(1):e001955. doi: 10.1136/openhrt-2021-001955.

    PMID: 35437257DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionCoronary Artery DiseaseThrombosis

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesEmbolism and Thrombosis

Study Officials

  • Joost Daemen, MD PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2021

First Posted

August 16, 2021

Study Start

November 10, 2020

Primary Completion

February 2, 2023

Study Completion

February 2, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)