NCT04646278

Brief Summary

Study for developing techniques to evaluate coronary artery hemodynamic profiles by conventional angiography without more dedicated measuring devices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

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

April 11, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

3 years

First QC Date

November 4, 2020

Last Update Submit

November 22, 2020

Conditions

Coronary Artery Disease

Keywords

coronary artery diseaseIndex of microcirculatory resistanceTIMI frame countFractional flow reserveCoronary flow reserve

Outcome Measures

Primary Outcomes (3)

  • TIMI frame count

    frame count between the beginning and end of contrast column head

    Imediately after the procedure

  • Coronary Clearance Frame Count

    frame count between the beginning and end of contrast column tail

    Imediately after the procedure

  • Index of microcirculatory resistance

    derived from distal coronary pressure by transit time

    During the procedure

Secondary Outcomes (2)

  • Fractional flow reserve

    During the procedure

  • Coronary flow reserve

    During the procedure

Study Arms (1)

Hyperemic stimuli

EXPERIMENTAL

Hyperemic stimuli of coronary flow by adenosine or nicorandil injection

Drug: Hyperemic stimuli

Interventions

Hyperemic stimuliDRUG

Hyperemic simuli of coronary flow by adenosine or nicorandil injection

Also known as: Hyperemia
Hyperemic stimuli

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who underwent physiologic study using a pressure wire for intermediate coronary lesion after coronary angiography

You may not qualify if:

  • ST elevation myocardial infarction
  • Cardiogenic shock
  • Congestive heart failure with pulmonary edema
  • LVEF \< 30%
  • Previous history of coronary revascularization
  • Chronic total occlusion
  • vessel disease
  • Target lesion at distal segments or branches

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangwon National University Hospital

Chuncheon, Gangwon-do, 24289, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bong-Ki Lee, MD, PhD

    KangWon National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Patients who underwent coronary angiography and further hyperemic stimui
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 27, 2020

Study Start

April 11, 2017

Primary Completion

March 25, 2020

Study Completion

March 25, 2020

Last Updated

November 27, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Could be shared after necessary discussions

Shared Documents
STUDY PROTOCOL
Time Frame
after publication
Access Criteria
Investigator who I permitted

Locations

KR(1)