Myocardial InfarctionNCT03218020
Red Meat, Increased Iron Load and CVD Risk
An observational study of Myocardial Infarction and Stroke, run by German Cancer Research Center at 1 site in Germany.
Trial summary
Increased iron load could be a risk factor for cardiovascular diseases (CVD). Red meat consumption affects iron status and has also been shown to be related to increased CVD risk. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Myocardial Infarction, Stroke, Cardiovascular Mortality
- How many people
- 25,540 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 1994to 31 Dec 2009
- 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 35 to 65 years
- All sexes
- Adult, Older adult
Study population: EPIC-Heidelberg was launched as part of EPIC-Europe between 1994 and 1998, when 13 611 female and 11 929 male participants aged 35 to 65 years were recruited from the local general population.
Who may be able to join
- General population, age 35-65 years
Who cannot join
- Prevalent myocardial infraction or stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Red Meat Consumption and Risk of Cardiovascular Diseases - is Increased Iron Load a Possible Link?
Increased iron load could be a risk factor for cardiovascular diseases (CVD). Red meat consumption affects iron status and has also been shown to be related to increased CVD risk. The investigators hypothesized that risk associations between red meat intake and cardiovascular disease risk can to some degree be explained by higher iron load among individuals with higher meat intake. Thus, the investigators evaluate associations between red meat consumption, iron status, and CVD risk in a large-scale population based study, the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg.
Read the detailed description
The present study part of the the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg, a large-scale observational cohort study located at the German Cancer Research Center, Heidelberg, Germany. The study started between 1994 and 1998, when 25 540 adults from the local general population were recruited. Study participants are being followed-up by active and passive procedures. The main aim of the study is to evaluate associations between diet, lifestyle as well as metabolism and risks of major chronic diseases (cancer, cardiovascular diseases, diabetes).
Here, the investigators register a project from within EPIC-Heidelberg on prediagnostic iron status as a potential mediator of associations between pre-diagnostic red meat consumption and cardiovascular disease risk. For this particular project, an embedded case-cohort set-up was chosen, i.e. iron status markers (primary marker: serum ferritin; secondary markers: serum transferrin, serum iron) were measured in baseline blood samples from a random subcohort (n=2738) and all validated incident cases of myocardial infarction (n=556), stroke (n=513), and CVD death (n=327) that occured until the closure date of the present study (12-31-2009).
Statistical analyses follow four steps to assess whether iron status may mediate associations between red meat consumption and CVD risk, as proposed by Wittenbecher et al. (Am J Clin Nutr, 2015: www.ncbi.nlm.nih.gov/pubmed/25948672):
- Multivariable Cox regression analyses on red meat consumption and CVD risk, assuming a significant positive association
- Multivariable linear regression analyses on red meat consumption and iron status, assuming a significant positive association
- Multivariable Cox regression analyses on iron status and CVD risk, assuming a significant positive association
- Multivariable Cox regression analyses on red meat consumption and CVD risk, additionally adjusting for iron status, assuming that the association will be attenuated by adjustment for iron status
- Conditions
- Myocardial Infarction, Stroke, Cardiovascular Mortality
- Being tested
- No intervention assigned, this is an observational study.
- Medical subject headings
- Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention assigned, this is an observational study.Other
No intervention assigned, this is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Random Subcohort | Random subcohort (~10 % of the initial cohort, study has a case-cohort design; details on the case-cohort design have been described by Kulathinal et al., Epidemiol Perspect Innov, 2007: www.ncbi.nlm.nih.gov/pmc/articles/PMC2216006/). Receives: Other: No intervention assigned, this is an observational study. | |
| Incident CVD Cases | Validated incident cases of myocardial infarction, stroke and CVD death that occured until Dec-31-2009 (details on the case-cohort design have been described by Kulathinal et al., Epidemiol Perspect Innov, 2007: www.ncbi.nlm.nih.gov/pmc/articles/PMC2216006/). Receives: Other: No intervention assigned, this is an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infraction
Incident cases of primary myocardial infarction according to clinical records
Measured: 1994 - 2009
Stroke
Incident cases of primary stroke according to clinical records
Measured: 1994 - 2009
Cardiovascular death
Incident cases of cardiovascular death according to death certificates
Measured: 1994 - 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Sep 1994
- Primary completion31 Dec 2009
- Study completion31 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- 25,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudolf Kaaks, Prof., Principal investigator, German Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218020
- Sponsor's protocol ID
- DKFZ Study_ID 905
- Status last verified
- Jul 2017
- First submitted
- 13 Jul 2017
- Last updated
- 18 Jul 2017
- 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 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Meat Consumption and Risk of Cardiovascular Diseases - is Increased Iron Load a Possible Link?
- ClinicalTrials.gov ID
- NCT03218020
- Acronym / sponsor ID
- DKFZ Study_ID 905
- Conditions
- Myocardial Infarction, Stroke, Cardiovascular Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,540 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Study start
- 1 Sep 1994 (actual)
- Primary completion
- 31 Dec 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 14 Jul 2017 (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.
Increased iron load could be a risk factor for cardiovascular diseases (CVD). Red meat consumption affects iron status and has also been shown to be related to increased CVD risk. The investigators hypothesized that risk associations between red meat intake and cardiovascular disease risk can to some degree be explained by higher iron load among individuals with higher meat intake. Thus, the investigators evaluate associations between red meat consumption, iron status, and CVD risk in a large-scale population based study, the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg.
Detailed description
The present study part of the the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg, a large-scale observational cohort study located at the German Cancer Research Center, Heidelberg, Germany. The study started between 1994 and 1998, when 25 540 adults from the local general population were recruited. Study participants are being followed-up by active and passive procedures. The main aim of the study is to evaluate associations between diet, lifestyle as well as metabolism and risks of major chronic diseases (cancer, cardiovascular diseases, diabetes).
Here, the investigators register a project from within EPIC-Heidelberg on prediagnostic iron status as a potential mediator of associations between pre-diagnostic red meat consumption and cardiovascular disease risk. For this particular project, an embedded case-cohort set-up was chosen, i.e. iron status markers (primary marker: serum ferritin; secondary markers: serum transferrin, serum iron) were measured in baseline blood samples from a random subcohort (n=2738) and all validated incident cases of myocardial infarction (n=556), stroke (n=513), and CVD death (n=327) that occured until the closure date of the present study (12-31-2009).
Statistical analyses follow four steps to assess whether iron status may mediate associations between red meat consumption and CVD risk, as proposed by Wittenbecher et al. (Am J Clin Nutr, 2015: www.ncbi.nlm.nih.gov/pubmed/25948672):
- Multivariable Cox regression analyses on red meat consumption and CVD risk, assuming a significant positive association
- Multivariable linear regression analyses on red meat consumption and iron status, assuming a significant positive association
- Multivariable Cox regression analyses on iron status and CVD risk, assuming a significant positive association
- Multivariable Cox regression analyses on red meat consumption and CVD risk, additionally adjusting for iron status, assuming that the association will be attenuated by adjustment for iron status
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Random Subcohort | – | Other: No intervention assigned, this is an observational study.Random subcohort (~10 % of the initial cohort, study has a case-cohort design; details on the case-cohort design have been described by Kulathinal et al., Epidemiol Perspect Innov, 2007: www.ncbi.nlm.nih.gov/pmc/articles/PMC2216006/). |
| Incident CVD Cases | – | Other: No intervention assigned, this is an observational study.Validated incident cases of myocardial infarction, stroke and CVD death that occured until Dec-31-2009 (details on the case-cohort design have been described by Kulathinal et al., Epidemiol Perspect Innov, 2007: www.ncbi.nlm.nih.gov/pmc/articles/PMC2216006/). |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- EPIC-Heidelberg was launched as part of EPIC-Europe between 1994 and 1998, when 13 611 female and 11 929 male participants aged 35 to 65 years were recruited from the local general population.
Key inclusion criteria (1 listed)
- General population, age 35-65 years
Key exclusion criteria (1 listed)
- Prevalent myocardial infraction or stroke
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 |
|---|---|---|
| No intervention assigned, this is an observational study.No intervention assigned, this is an observational study. | Other | Incident CVD Cases, Random Subcohort |
Primary outcome
Myocardial infraction
Time frame: 1994 - 2009
Incident cases of primary myocardial infarction according to clinical records
Stroke
Time frame: 1994 - 2009
Incident cases of primary stroke according to clinical records
Cardiovascular death
Time frame: 1994 - 2009
Incident cases of cardiovascular death according to death certificates
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 18 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
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.
Rudolf Kaaks, Prof. principal investigator
German Cancer Research Center
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 Myocardial Infarction and Stroke, run by German Cancer Research Center 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 18 Jul 2017. 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?
Myocardial infraction (time frame: 1994 - 2009). The study lists 3 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 18 Jul 2017.