Cardiovascular DiseaseCalcitopNCT02192528
Vitamin D and Outcome in Cardiac Surgery
An observational study of Cardiovascular Disease, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
We will use a retrospective data analysis to evaluate the association of the two vitamin D metabolites 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D with clinical outcome in cardiac surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 3,852 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Jul 2014
- 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: cardiac surgical patients
Who may be able to join
- cardiac surgical patients aged 18 years and older
Who cannot join
- age < 18 years
- heart transplant recipients
- pacemaker or defibrillator implantation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heart & Diabetes Center North-Rhine Westphalia
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
Official title: 25-Hydroxyvitamin D, 1,25-Dihydroxyvitamin D and Postoperative Outcome in Cardiac Surgical Patients
We will use a retrospective data analysis to evaluate the association of the two vitamin D metabolites 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D with clinical outcome in cardiac surgical patients. The occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. In addition, we will assess the association of the two vitamin D metaboolites with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according to vitamin D metabolite levels.
Read the detailed description
In a retrospective data analysis, we will evaluate the association of vitamin D metabolites (circulating 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D) with MACCE (major cardiac or cerebrovascular event) in cardiac surgical patients. The occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. Approximately 4,000 data sets from mid of 2012 until the end of 2013 will be analyzed. In all patients, we will also assess the association of vitamin D metabolite levels with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according to vitamin D status
- Conditions
- Cardiovascular Disease
- Keywords
- vitamin D, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, MACCE, mortality, cardiac, cerebrovascular
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgical patients | patients undergoing a cardiac surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
major cardiac or cerebrovascular event (MACCE)
MACCE is defined as in-hospital death, myocardial infarction, low cardiac output syndrome or stroke.
Measured: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
Secondary outcomes (4)
duration of ventilatory support
Measured: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
intensive care unit stay
Measured: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
in-hospital stay
Measured: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
infection
Measured: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2012
- Primary completionNov 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular 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
- Prospective
- Enrolment
- 3,852 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin Zittermann, PhD, Principal investigator, Heart & Diabetes Center North-Rhine Westfalia, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192528
- Sponsor's protocol ID
- 008
- Acronym
- Calcitop
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zittermann A, Kuhn J, Dreier J, Knabbe C, Gummert JF, Borgermann J. Vitamin D status and the risk of major adverse cardiac and cerebrovascular events in cardiac surgery. Eur Heart J. 2013 May;34(18):1358-64. doi: 10.1093/eurheartj/ehs468. Epub 2013 Jan 12.
PubMed 23315905
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 25-Hydroxyvitamin D, 1,25-Dihydroxyvitamin D and Postoperative Outcome in Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT02192528
- Acronym / sponsor ID
- Calcitop / 008
- Conditions
- Cardiovascular Disease
- Keywords
- vitamin D, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, MACCE, mortality, cardiac, cerebrovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,852 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Jul 2014 (estimated)
- 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.
We will use a retrospective data analysis to evaluate the association of the two vitamin D metabolites 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D with clinical outcome in cardiac surgical patients. The occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. In addition, we will assess the association of the two vitamin D metaboolites with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according to vitamin D metabolite levels.
Detailed description
In a retrospective data analysis, we will evaluate the association of vitamin D metabolites (circulating 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D) with MACCE (major cardiac or cerebrovascular event) in cardiac surgical patients. The occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. Approximately 4,000 data sets from mid of 2012 until the end of 2013 will be analyzed. In all patients, we will also assess the association of vitamin D metabolite levels with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according to vitamin D status
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac surgical patients | – | –patients undergoing a cardiac surgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cardiac surgical patients
Key inclusion criteria (1 listed)
- cardiac surgical patients aged 18 years and older
Key exclusion criteria (3 listed)
- age < 18 years
- heart transplant recipients
- pacemaker or defibrillator implantation
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
major cardiac or cerebrovascular event (MACCE)
Time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
MACCE is defined as in-hospital death, myocardial infarction, low cardiac output syndrome or stroke.
4 secondary outcomes
duration of ventilatory support
Time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
intensive care unit stay
Time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
in-hospital stay
Time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
infection
Time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
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 11 Aug 2016.
- Background: PubMed 23315905Zittermann A, Kuhn J, Dreier J, Knabbe C, Gummert JF, Borgermann J. Vitamin D status and the risk of major adverse cardiac and cerebrovascular events in cardiac surgery. Eur Heart J. 2013 May;34(18):1358-64. doi: 10.1093/eurheartj/ehs468. Epub 2013 Jan 12.
- Individual participant dataSharing planned: No
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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.
Armin Zittermann, PhD principal investigator
Heart & Diabetes Center North-Rhine Westfalia, Germany
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 Disease, run by Heart and Diabetes Center North-Rhine Westfalia 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 3 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 11 Aug 2016. 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?
major cardiac or cerebrovascular event (MACCE) (time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02192528, which also lists 1 linked publication.
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 11 Aug 2016.