NCT04169516

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

November 14, 2019

Last Update Submit

November 17, 2019

Conditions

Keywords

microcirculation

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline index of microcirculatory resistance at 6 months

    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.

    baseline and 6-month

Interventions

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).

Also known as: 13N-ammonia positron emission tomography

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute coronary syndrome

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 20, 2019

Study Start

December 1, 2014

Primary Completion

December 31, 2015

Study Completion

November 10, 2019

Last Updated

November 20, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share