Cardiovascular DiseasesNCDRNCT03671356
Risk Management in Interventional Cardiology - a Quality Management Single-center Registry
An observational study of Cardiovascular Diseases, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The validity and applicability of different clinical risk scoring models in a variety of settings of interventional cardiology is evaluated in a retrospective and continuing prospective single-center registry at University Hospital Düsseldorf. Risk-adapted safety interventions are additionally tested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- risk score
- How many people
- 2,067 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: All consenting adult patients undergoing cardiac catheterization at University Hospital Düsseldorf, Germany
Who may be able to join
- >18 yeas of age, written informed consent, cardiac catheterization at university hospital Düsseldorf, Germany
Who cannot join
- no written informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
The validity and applicability of different clinical risk scoring models in a variety of settings of interventional cardiology is evaluated in a retrospective and continuing prospective single-center registry at University Hospital Düsseldorf. Risk-adapted safety interventions are additionally tested.
Read the detailed description
Beginning with a retrospective assessment of 2014-2017 and continuing with a prospective registry, clinical outcomes of interventional cardiac catheterization procedures at University Hospital Düsseldorf in a variety of settings (elective and emergency coronary procedures, structural and rhythmologic cardiac interventions etc.), will be evaluated. Different risk scoring models are recommended for risk stratification by cardiovascular societies (e.g. GRACE, CRUSADE, NCDR, ACEF, EUROScore scores) and will be evaluated for their applicability to contemporary and local clinical practice in interventional cardiology. Risk-adapted safety interventions (e.g. intensified monitoring, vascular access closure, renal protective measures) will be applied to all patients and will be evaluated for their impact on clinical outcomes.
- Conditions
- Cardiovascular Diseases
- Being tested
- risk score
- Keywords
- risk score, risk management, NCDR, interventional cardiology
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risk scoreOther
risk score
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
In-hospital mortality will be assessed and primarily reported
Measured: 30 days
Secondary outcomes (5)
Bleeding (according to BARC bleeding definition)
in-hospital and long-term minor and major bleeding up to five years post procedure will be assessed and reported
Measured: 30 days and up to 5 years post procedure
Acute and chronic kidney injury (according to KDIGO definitions)
in-hospital and long-term acute and chronic kidney injury up to five years post procedure will be assessed and reported
Measured: 30 days and up to 5 years post procedure
TIA and Stroke
in-hospital and long-term cerebrovascular events (TIA and stroke) up to five years post procedure will be assessed and reported
Measured: 30 days and up to 5 years post procedure
Quality of life (assessed by standardized QoL surveys)
in-hospital and long-term impact of interventional procedures on quality of life up to five years post procedure will be assessed and reported
Measured: 30 days and up to 5 years post procedure
Long-term mortality
long-term mortality up to five years post procedure will be assessed and report
Measured: up to 5 years post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- 2,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, MD, Study chair, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671356
- Sponsor's protocol ID
- 18-007
- Acronym
- NCDR
- Status last verified
- Mar 2024
- First submitted
- 21 Aug 2018
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Management in Interventional Cardiology - a Quality Management Single-center Registry
- ClinicalTrials.gov ID
- NCT03671356
- Acronym / sponsor ID
- NCDR / 18-007
- Conditions
- Cardiovascular Diseases
- Keywords
- risk score, risk management, NCDR, interventional cardiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,067 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Sep 2018 (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.
The validity and applicability of different clinical risk scoring models in a variety of settings of interventional cardiology is evaluated in a retrospective and continuing prospective single-center registry at University Hospital Düsseldorf. Risk-adapted safety interventions are additionally tested.
Detailed description
Beginning with a retrospective assessment of 2014-2017 and continuing with a prospective registry, clinical outcomes of interventional cardiac catheterization procedures at University Hospital Düsseldorf in a variety of settings (elective and emergency coronary procedures, structural and rhythmologic cardiac interventions etc.), will be evaluated. Different risk scoring models are recommended for risk stratification by cardiovascular societies (e.g. GRACE, CRUSADE, NCDR, ACEF, EUROScore scores) and will be evaluated for their applicability to contemporary and local clinical practice in interventional cardiology. Risk-adapted safety interventions (e.g. intensified monitoring, vascular access closure, renal protective measures) will be applied to all patients and will be evaluated for their impact on clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consenting adult patients undergoing cardiac catheterization at University Hospital Düsseldorf, Germany
Key inclusion criteria (1 listed)
- >18 yeas of age, written informed consent, cardiac catheterization at university hospital Düsseldorf, Germany
Key exclusion criteria (1 listed)
- no written 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| risk scorerisk score | Other | – |
Primary outcome
mortality
Time frame: 30 days
In-hospital mortality will be assessed and primarily reported
5 secondary outcomes
Bleeding (according to BARC bleeding definition)
Time frame: 30 days and up to 5 years post procedure
Acute and chronic kidney injury (according to KDIGO definitions)
Time frame: 30 days and up to 5 years post procedure
TIA and Stroke
Time frame: 30 days and up to 5 years post procedure
Quality of life (assessed by standardized QoL surveys)
Time frame: 30 days and up to 5 years post procedure
Long-term mortality
Time frame: up to 5 years post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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. This study is not recruiting at the moment.
Malte Kelm, MD study chair
Heinrich-Heine University, Duesseldorf
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 Cardiovascular Diseases, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 15 Mar 2024. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 30 days). 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 15 Mar 2024.