Localization of Microvascular Dysfunction

NCT ID: NCT04169516

Last Updated: 2019-11-20

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

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-01

Study Completion Date

2019-11-10

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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index of microcirculatory resistance

Physiological parameters of the culprit artery after PCI were determined with the restoration of Thrombolysis in Myocardial Infarction (TIMI) 3 flow. Aortic pressure (Pa), distal intracoronary pressure (Pd), fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) were measured using a 0.014 coronary temperature and pressure-sensing guidewire (PressureWireCertus, ST. Jude Medical, MN, USA).

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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13N-ammonia positron emission tomography

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A University

OTHER

Sponsor Role lead

Responsible Party

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Kyungil Park

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Jo YS, Moon H, Park K. Different Microcirculation Response Between Culprit and Non-Culprit Vessels in Patients With Acute Coronary Syndrome. J Am Heart Assoc. 2020 May 18;9(10):e015507. doi: 10.1161/JAHA.119.015507. Epub 2020 May 15.

Reference Type DERIVED
PMID: 32410526 (View on PubMed)

Other Identifiers

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11-95

Identifier Type: -

Identifier Source: org_study_id

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