Optical Coherence Tomography in STEMI

May 31, 2016 updated by: National Heart Centre Singapore

Plaque Evaluation by Optical Coherence Tomography and Its Association With Microvascular Obstruction in Reperfused STEMI Patients - The POMS Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The specific research objectives include:

  1. To use OCT to determine the type of plaque (plaque rupture, plaque erosion or calcified nodule) most associated with the presence and severity of MVO (as measured by IMR and cardiac MRI).
  2. To use OCT to investigate the relationship between the extent of tissue protrusion and the amount of residual stent thrombus with the presence and severity of MVO (as measured by IMR and cardiac MRI).

Study Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 169609
        • Recruiting
        • National Heart Centre Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Confirmed STEMI as per the in-charge consultant based on presenting history, ECG and angiogram findings.
  2. < 12 hours of onset of chest pain.
  3. Ability to provide informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Special camera to study part of your heart that was affected
Procedure: Index of microcirculatory resistance (IMR)
Special wire to study part of your heart that was affected
Other: Cardiac MRI
Special scanner if the heart to assess the damage of your heart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart Centre Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ANTICIPATED)

January 1, 2018

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (ESTIMATE)

June 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 6, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/3034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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