Comparison of treatment strategy for Multi-Vessel Disease (MVD) patients between conventional angiography and FFR based on SYNTAX score in a real-world scenario

Not Applicable

• Conditions: Health Condition 1: I248- Other forms of acute ischemic heart disease

• Registration Number: CTRI/2020/09/027770
• Lead Sponsor: Dr Nattawut Wongpraparut from Faculty of Medicine Siriraj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age >18 years

2. Willing to participate and able to understand, read and sign the informed consent document before the planned procedure

3. Eligible for coronary angiography and/or percutaneous coronary intervention

4. Stable angina

5. Recent and stabilized NSTEMI

Angiographic inclusion criteria

- Coronary artery disease in two or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which one of the lesion has the physiological severity of the lesion is in question (typically 50-90% diameter stenosis)

- All lesions are amenable to revascularization 

Exclusion Criteria

- Terminal disease with life expectancy of less than 12 months

- Any patient who at the time of planned angiography has ongoing ischemic symptoms

- Angiography performed in the context of primary PCI of STEMI

- Acute coronary syndrome with difficulty in assessing the culprit lesion

- Pregnancy

- Severe aortic stenosis

- Significant valvular heart disease indicated for concomitant valve surgery

- Cardiogenic shock or hemodynamic instability

- Contraindication to adenosine

- Previous CABG

- Additional investigations planned for the assessment of myocardial viability.

- Severe asthma

Angiographic exclusion criteria

- Heavily calcified or tortuous vessels that in the opinion of the investigator would result in uncrossable of pressure wire

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in treatment strategy after physiologic assessment <br/ ><br> <br/ ><br>Healthcare costs <br/ ><br>Timepoint: In-hospital and at 1 year

Secondary Outcome Measures

Name	Time	Method
The percentage rate of concordance between FFR and RFR  <br/ ><br> <br/ ><br>Procedural time <br/ ><br>Level of agreement in the decision-making strategy based on invasive angiography and physiologic assessment <br/ ><br>Functional SYNTAX score calculation based on FFR <br/ ><br> <br/ ><br>Composite of MACCE (all-cause death, documented myocardial infarction, stroke or unplanned revascularization) <br/ ><br> <br/ ><br>Rates of individual components of MACE <br/ ><br> <br/ ><br>Change in health status of patients from baselineTimepoint: IN-Hospital, 30 days and 1 year