Optical Coherence Tomography in STEMI

NCT ID: NCT02791178

Last Updated: 2016-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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STEMI

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Optical coherence tomography (OCT)

Intervention Type PROCEDURE

Special camera to study part of your heart that was affected

Index of microcirculatory resistance (IMR)

Intervention Type PROCEDURE

Special wire to study part of your heart that was affected

Cardiac MRI

Intervention Type OTHER

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

Interventions

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Optical coherence tomography (OCT)

Special camera to study part of your heart that was affected

Intervention Type PROCEDURE

Index of microcirculatory resistance (IMR)

Special wire to study part of your heart that was affected

Intervention Type PROCEDURE

Cardiac MRI

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart Centre Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Derek Hausenloy

Role: PRINCIPAL_INVESTIGATOR

National Heart Centre Singapore

Locations

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National Heart Centre Singapore

Singapore, Singapore, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Mung Peng

Role: CONTACT

6704 ext. 2267

Derek Hausenloy

Role: CONTACT

Facility Contacts

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Mung Peng

Role: primary

6704 ext. 2267

Other Identifiers

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2015/3034

Identifier Type: -

Identifier Source: org_study_id

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