Coronary Artery DiseaseNCT03479840
Age-Dependent Impact of the SYNTAX-score on Mortality
An observational study of Coronary Artery Disease and PCI, run by LMU Klinikum at 1 site in Germany.
Trial summary
The SYNTAX-score has been proposed as a tool for risk stratification and guiding revascularization therapy in patients with complex coronary artery disease. There are limited data on the prognostic value of the SYNTAX-score among elderly patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, PCI
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- How many people
- 1,331 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2013to 31 Dec 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All-comer population undergoing PCI
Who may be able to join
- patients undergoing PCI at our center
Who cannot join
- prior coronary artery bypass grafting
- no PCI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Age-Dependent Impact of the SYNTAX-score on Mortality After Percutaneous Coronary Intervention in an All-Comer Population
The SYNTAX-score has been proposed as a tool for risk stratification and guiding revascularization therapy in patients with complex coronary artery disease.
There are limited data on the prognostic value of the SYNTAX-score among elderly patients.
Aim of this study was to investigate whether age modifies the impact of the SYNTAX-score on all-cause mortality at 2 years after percutaneous coronary intervention (PCI).
Read the detailed description
SYNTAX score has been used as a tool to quantify severity of coronary artery disease. Interventional or operative treatment of patients is associated with improvement in SYTAX score after PCI so called residual SYNTAX score. The higher the SYNTAX score value the higher is the mortality. Whereas this is true for both young and old patients is debatable. Therefore we aim to investigate in this registry age-dependent impact of baseline and residual SYNTAX score on 1- and 2-year mortality after PCI
- Conditions
- Coronary Artery Disease, PCI
- Being tested
- PCI
- Keywords
- SYNTAX score, PCI, elderly
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Also called percutaneous coronary intervention
treatment of coronary arteries and evaluation of SYNTAX score pre and post (to quantify severity of disease)
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing PCI | all-comer population undergoing PCI Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medium- to long-term Mortality
Overall mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Jan 2013
- Primary completion31 Mar 2014
- Study completion31 Dec 2016
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.
- 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
- Retrospective
- Enrolment
- 1,331 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Julinda Mehilli, LMU Klinikum
- Investigators
- Julinda Mehilli, MD, Principal investigator, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479840
- Sponsor's protocol ID
- GEMucI003-16
- Status last verified
- Aug 2018
- First submitted
- 20 Mar 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Dependent Impact of the SYNTAX-score on Mortality After Percutaneous Coronary Intervention in an All-Comer Population
- ClinicalTrials.gov ID
- NCT03479840
- Acronym / sponsor ID
- GEMucI003-16
- Conditions
- Coronary Artery Disease, PCI
- Keywords
- SYNTAX score, PCI, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,331 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Mar 2014 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 27 Mar 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 SYNTAX-score has been proposed as a tool for risk stratification and guiding revascularization therapy in patients with complex coronary artery disease.
There are limited data on the prognostic value of the SYNTAX-score among elderly patients.
Aim of this study was to investigate whether age modifies the impact of the SYNTAX-score on all-cause mortality at 2 years after percutaneous coronary intervention (PCI).
Detailed description
SYNTAX score has been used as a tool to quantify severity of coronary artery disease. Interventional or operative treatment of patients is associated with improvement in SYTAX score after PCI so called residual SYNTAX score. The higher the SYNTAX score value the higher is the mortality. Whereas this is true for both young and old patients is debatable. Therefore we aim to investigate in this registry age-dependent impact of baseline and residual SYNTAX score on 1- and 2-year mortality after PCI
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing PCI | – | Procedure: PCIall-comer population undergoing PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comer population undergoing PCI
Key inclusion criteria (1 listed)
- patients undergoing PCI at our center
Key exclusion criteria (2 listed)
- prior coronary artery bypass grafting
- no PCI
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 |
|---|---|---|
| PCIAlso: percutaneous coronary interventiontreatment of coronary arteries and evaluation of SYNTAX score pre and post (to quantify severity of disease) | Procedure or surgery | Patients undergoing PCI |
Primary outcome
Medium- to long-term Mortality
Time frame: 2 years
Overall mortality
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 9 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
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.
Julinda Mehilli, MD principal investigator
LMU Klinikum
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 and PCI, run by LMU Klinikum 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 2 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 9 Aug 2018. 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?
Medium- to long-term Mortality (time frame: 2 years). 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 9 Aug 2018.