Localization of Microvascular Dysfunction

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT04169516
• Lead Sponsor: Dong-A University

Brief Summary

Microvascular dysfunction is an independent predictor of poor prognosis. Such response in the culprit vessel is common even after successful revascularization. This study investigated whether the microvascular dysfunction differed between culprit and non-culprit vessels in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI).

Detailed Description

The prospective study included 115 patients with ACS. In this study, after successful PCI, culprit and non-culprit intracoronary hemodynamic measurements were performed and repeated at 6-month follow-up. 13N-ammonia positron emission tomography (PET) was performed at 6-month follow-up visit to determine absolute myocardial blood flow (MBF). The resistance values of each vessel were calculated using the coronary pressure data and the MBF values obtained from 13N-ammonia PET data. Such physiological measures were compared between culprit and non-culprit vessels in baseline and 6-month follow-up.

Study Timeline

• Study Start: 2014-12-01
• Primary Completion: 2015-12-31
• Status Verified: 2019-11
• Study Completion: 2019-11-10
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-17
• Last Update Submitted: 2019-11-17
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• Individuals were eligible for inclusion if they underwent PCI for ACS, if the target lesion was found in the proximal or middle segments of a major epicardial coronary artery, and if the lesion was successfully treated with a coronary stent.

Exclusion Criteria

• a previous infarction other than in the vessel of interest or a history of coronary artery bypass surgery, cardiogenic shock requiring inotropic support, chronic kidney disease requiring renal replacement therapy, hypertrophic cardiomyopathy, collateral flow to the target vessel greater than angiographic grade 1, or statin or ticagrelor use within 1 year.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline index of microcirculatory resistance at 6 months	baseline and 6-month	Physiological parameters of the culprit artery after PCI were determined with the restoration of Thrombolysis in Myocardial Infarction (TIMI) 3 flow. Index of microcirculatory resistance (IMR) were measured using a 0.014 coronary temperature and pressure-sensing guidewire (PressureWireCertus, ST. Jude Medical, MN, USA). These parameters were then determined for non-culprit vessels.