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RecruitingNCT04815928ICA-PIUpdated Jun 8, 2021

Registry of Patients That Have Undergone ICA or PCI

An observational study in Coronary Artery Disease, sponsored by Amsterdam UMC, location VUmc. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-08.

Sponsored by Amsterdam UMC, location VUmc · Observational

From the registry’s dates

  • Started Jul 2020; still recruiting 6 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Quantiative Flow Ratio
  • QFR
  • Fractional Flow Reserve
  • FFR
  • Instantaneous wave-free ratio
  • iFR
  • Invasive Coronary Angiography
  • Percutaneous Coronary Intervention
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not willing / unable to provide informed consent.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Fractional Flow Reserve (FFR)

    Invasively obtained FFR

    Time frame: Upon inclusion at index procedure

  2. Instantaneous wave-free ratio (iFR)

    Invasively obtained iFR

    Time frame: Upon inclusion at index procedure

  3. Quantitative Flow Ratio (QFR)

    Invasively obtained QFR

    Time frame: Upon inclusion at index procedure

  4. Stenosis percentage

    Invasively obtained stenosis percentage

    Time frame: Upon inclusion at index procedure

Secondary outcomes

  1. Major adverse cardiac events, cardiac death or repeat revascularization

    The secondary endpoint is to assess the prognostic value of the obtained parameters.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Amsterdam Univeristy Medical centers, location VUmc
    Amsterdam, Netherlands
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04815928
Lead sponsor
Amsterdam UMC, location VUmc
Responsible party
Paul Knaapen (Principal Investigator, Amsterdam UMC, location VUmc) — Principal investigator
First posted
Mar 25, 2021
Start date
Jul 1, 2020
Primary completion
Jul 1, 2035 (estimated)
Completion
Jul 1, 2035 (estimated)
Last update
Jun 8, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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