NCT04815928

Brief Summary

In Invasive Coronary Angiography there are multiple invasively obtained measurements to determine the funcitonal significance of Cornary Artery Disease. In this Registry, patients who have undergone Invasive Coronary Angiography or Percutaneous Coronary Intervention are included to investigate diagnostic and prognostic implications of the invasive measurements.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
110mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress40%
Jul 2020Jul 2035

Study Start

First participant enrolled

July 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
14.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2035

Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

15 years

First QC Date

March 18, 2021

Last Update Submit

June 2, 2021

Conditions

Coronary Artery Disease

Keywords

Quantiative Flow RatioQFRFractional Flow ReserveFFRInstantaneous wave-free ratioiFRInvasive Coronary AngiographyPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (4)

  • Fractional Flow Reserve (FFR)

    Invasively obtained FFR

    Upon inclusion at index procedure

  • Instantaneous wave-free ratio (iFR)

    Invasively obtained iFR

    Upon inclusion at index procedure

  • Quantitative Flow Ratio (QFR)

    Invasively obtained QFR

    Upon inclusion at index procedure

  • Stenosis percentage

    Invasively obtained stenosis percentage

    Upon inclusion at index procedure

Secondary Outcomes (1)

  • Major adverse cardiac events, cardiac death or repeat revascularization

    5 years

Eligibility Criteria

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

All patients that have undergone an invasive coronary angiography and or/percutaneous coronary intervention

You may qualify if:

  • years
  • Has undergone or will undergo a clinically indicated invasive coronary angiography.
  • Has undergone or will undergo a clinically indicated percutaneous coronary intervention.

You may not qualify if:

  • Not willing / unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam Univeristy Medical centers, location VUmc

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 25, 2021

Study Start

July 1, 2020

Primary Completion (Estimated)

July 1, 2035

Study Completion (Estimated)

July 1, 2035

Last Updated

June 8, 2021

Record last verified: 2021-06

Locations

NL(1)