Coronary Artery DiseaseICA-PINCT04815928
Registry of Patients That Have Undergone ICA or PCI
An observational study of Coronary Artery Disease, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 10,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2020to 1 Jul 2035
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that have undergone an invasive coronary angiography and or/percutaneous coronary intervention
Who may be able to join
- 18 years
- Has undergone or will undergo a clinically indicated invasive coronary angiography.
- Has undergone or will undergo a clinically indicated percutaneous coronary intervention.
Who cannot join
- Not willing / unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam Univeristy Medical centers, location VUmc
Amsterdam
Ruurt Jukema, MD, PhD student, +3120-4443272, r.jukema@amsterdamumc.nl
About this study
Official title: Registry of Patients That Have Undergone an Invasive Coronary Angiography and/or Percutaneous Coronary Intervention
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.
- Conditions
- Coronary Artery Disease
- Keywords
- Quantiative Flow Ratio, QFR, Fractional Flow Reserve, FFR, Instantaneous wave-free ratio, iFR, Invasive Coronary Angiography, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Flow Reserve (FFR)
Invasively obtained FFR
Measured: Upon inclusion at index procedure
Instantaneous wave-free ratio (iFR)
Invasively obtained iFR
Measured: Upon inclusion at index procedure
Quantitative Flow Ratio (QFR)
Invasively obtained QFR
Measured: Upon inclusion at index procedure
Stenosis percentage
Invasively obtained stenosis percentage
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Jul 2020
- Primary completion1 Jul 2035 (estimated)
- Study completion1 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Knaapen, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815928
- Sponsor's protocol ID
- ICA-PI
- Acronym
- ICA-PI
- Status last verified
- Jun 2021
- First submitted
- 18 Mar 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Patients That Have Undergone an Invasive Coronary Angiography and/or Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04815928
- Acronym / sponsor ID
- ICA-PI / ICA-PI
- Conditions
- Coronary Artery Disease
- Keywords
- Quantiative Flow Ratio, QFR, Fractional Flow Reserve, FFR, Instantaneous wave-free ratio, iFR, Invasive Coronary Angiography, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2035 (estimated)
- Study completion
- 1 Jul 2035 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that have undergone an invasive coronary angiography and or/percutaneous coronary intervention
Key inclusion criteria (3 listed)
- 18 years
- Has undergone or will undergo a clinically indicated invasive coronary angiography.
- Has undergone or will undergo a clinically indicated percutaneous coronary intervention.
Key exclusion criteria (1 listed)
- Not willing / unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fractional Flow Reserve (FFR)
Time frame: Upon inclusion at index procedure
Invasively obtained FFR
Instantaneous wave-free ratio (iFR)
Time frame: Upon inclusion at index procedure
Invasively obtained iFR
Quantitative Flow Ratio (QFR)
Time frame: Upon inclusion at index procedure
Invasively obtained QFR
Stenosis percentage
Time frame: Upon inclusion at index procedure
Invasively obtained stenosis percentage
1 secondary outcome
Major adverse cardiac events, cardiac death or repeat revascularization
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amsterdam Univeristy Medical centers, location VUmc
Amsterdam, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional Flow Reserve (FFR) (time frame: Upon inclusion at index procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.