Optical Coherence Tomography in STEMI

• Conditions: STEMI
• Interventions: Procedure: Optical coherence tomography (OCT); Procedure: Index of microcirculatory resistance (IMR); Other: Cardiac MRI

• Registration Number: NCT02791178
• Lead Sponsor: National Heart Centre Singapore

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.

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 Timeline

• Study Start: 2016-02
• Status Verified: 2016-05
• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-05-31
• Last Update Submitted: 2016-05-31
• Study First Posted: 2016-06-06
• Last Update Posted: 2016-06-06
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
STEMI patients	Cardiac MRI	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.
STEMI patients	Optical coherence tomography (OCT)	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.
STEMI patients	Index of microcirculatory resistance (IMR)	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.

Primary Outcome Measures

Name	Time	Method
All cause mortality	Two years

Trial Locations

Locations (1)

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore