NCT02791178

Brief Summary

The overall objective of this research proposal is to use OCT to investigate those morphological culprit plaque characteristics associated with the risk of developing MVO in reperfused STEMI patients.

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
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

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

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

June 6, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

May 31, 2016

Last Update Submit

May 31, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    Two years

Study Arms (1)

STEMI patients

The patients presenting with a STEMI and undergoing PPCI will be screened and approached to participate in this study. All patients to do Optical Coherence Tomography (OCT), Index of Microcirculatory Resistance (IMR) and Cardiac MRI.

Procedure: Optical coherence tomography (OCT)Procedure: Index of microcirculatory resistance (IMR)Other: Cardiac MRI

Interventions

Special camera to study part of your heart that was affected

STEMI patients

Special wire to study part of your heart that was affected

STEMI patients

Special scanner if the heart to assess the damage of your heart

STEMI patients

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients presenting with a STEMI and undergoing PPCI will be screened and approached to participate in this study.

You may qualify if:

  • Confirmed STEMI as per the in-charge consultant based on presenting history, ECG and angiogram findings.
  • \< 12 hours of onset of chest pain.
  • Ability to provide informed consent

You may not qualify if:

  • Previous myocardial infarction or coronary artery bypass graft surgery
  • Cardiac arrest or cardiogenic shock
  • Inability to advance the OCT catheter or to obtain good image quality
  • Ostial lesions
  • Significant renal impairment
  • Contraindications for cardiac MRI
  • Contraindication for adenosine (for IMR measurement)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Centre Singapore

Singapore, Singapore, 169609, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected from all participants.

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Derek Hausenloy

    National Heart Centre Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek Hausenloy

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 6, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

June 6, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations