Ischemic Heart DiseaseOMIC-CARDNCT05706519
Metabolomics, Genomics and Nutrition for Cardiovascular Disease Precision Medicine
An observational study of Ischemic Heart Disease and Coronary Heart Disease, run by Fundacion Miguel Servet at 6 sites in Spain.
Trial summary
The objective of this project is to validate, through high-throughput advanced metabolomics techniques, the nutritional assessment tools to be used in the IMPaCT cohort. At the same time, the ability of metabolomics fingerprints of nutritional patterns to discriminate between patients with and without major… Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Heart Disease, Coronary Heart Disease
- How many people
- 1,200 participants
- Where
- 6 sitesSpain
- Study dates
- 19 Dec 2022to May 2024
- How long will I take part?
- 1 Year
- 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 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Six recruitment nodes were established, each one from a different Autonomous Community (Andalusia, Cantabria, The Balearic Islands, Madrid, Navarra, and the Basque Country), Comprising cardiologist and primary care clinicians. In each of the 6 nodes, 100 participants without ischemic heart disease (ICD) will be recruited for the control group and another 100 for the case group. The controls will be selected through the health Centers, The cases will be selected in CS and in Cardiology consultations of the National Health Service (NHS).
Who may be able to join
- Age between 50 - 79 years old
- Living in Spain for more than 2 years
- Fluent in Spanish
- Ability for answer all the study questionaries'
- Ability to validly grant informed consent
- Ability to move on one's own
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- Not under palliative care due to serious illness, institutionalized population will not be recruited
- Not planning any change of address to another autonomous community within a year.
- Receive health care in National Health System. Officials or self-employed workers with health coverage exclusively in "Mutuas" that do not allow telematics access to health data will be excluded.
Who cannot join
- Chronic alcoholism or regular alcohol consumption > 80 g/d
- BMI >40 kg/m²
- Participation in a clinical trial conducted with drugs or use of any drug in experimental status during the year prior to inclusion
- Patient with cancer treatment two years before
- Patient with history of gastrectomy or intestinal resection. Patients with acute infection or inflammatory process (e.g. Pneumonia), may be included in the study three months after the infectious process.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Not yet recruiting
ibs.GRANADA
Granada, Andalusia, 18012
José J Jiménez Moleón, Doctor, 958241000 ext. 20289, jjmoleon@ugr.es
- Recruiting
UAM
Madrid, 28029
Mercedes Sotos-Prieto, Doctor, 914975442, mercedes.sotos@uam.es
- Recruiting
Institut D' Investigació Sanitària Illes Balears
Palma de Mallorca, Balearic Islands, 07122
María A Romaguera, Doctor, 971173000, mariaadoracion@ssib.es
- Not yet recruiting
Servicio Navarro de Salud Osasunbidea
Pamplona, Navarre, 31006
Pilar Buil-Cosiales, Doctor, 948290480, pilar.buil.cosiales@navarra.es
- Not yet recruiting
Universidad de Cantabria
Santander, Cantabria, 39011
Inés Gómez Acebo, Doctor, 942201993, ines.gomez@unican.es
- Not yet recruiting
Instituto de Investigación Sanitaria
Vitoria-Gasteiz, Araba, 01009
Lucas Tojal Sierra, Doctor, 945007288, lutojal@hotmail.com
About this study
The objective of this project is to validate, through high-throughput advanced metabolomics techniques, the nutritional assessment tools to be used in the IMPaCT cohort. At the same time, the ability of metabolomics fingerprints of nutritional patterns to discriminate between patients with and without major cardiovascular disease will be identified. Finally, the modification of these predictions will be evaluated based on the genetic profiles. The main hypothesis holds that the integration of metabolomics, genomic and nutritional information will serve to personalize the approach to cardiovascular disease, both in prevention and treatment, and that these tools, in turn, will be valid enough to be applied systematically and efficiently in the IMPaCT cohort.
Read the detailed description
In two independent samples, one of 600 subjects free of cardiovascular disease (control group) and the other of 600 subjects with a history of ischemic heart disease (established heart disease group) eating habits will be evaluated using Food Frequency Questionnaire, based on those repeatedly used in epidemiological studies carried out in Spain, as well as other nutritional evaluation tools. Each participant will undergo a complete plasma metabolomics profile with identification of > 300 metabolites and a complete genome-wide association analysis. Artificial intelligence models and elastic net regression self-learning algorithms will be applied to select the metabolomics fingerprint of eating patterns.
The objectives are:
- To assess whether the relationship between diet and metabolic footprint is similar in those with established Cardio Vascular Disease or not. This will allow evaluating the usefulness of metabolic fingerprint to monitor the metabolic response to diet in patients with Cardio Vascular Disease and thus help to individualize their pharmacological and non-pharmacological treatment (diet and lifestyle)
- If there are sociodemographic characteristics - including the gender perspective-, clinical or genetic characteristics that help identify people who present a greater metabolic response to diet both in people without and in people with Cardio Vascular Disease.
- If the possible limitations of the metabolic footprint of different dietary patterns are reduced by using different tools for the collection of nutritional information. Self -completed Food Frequency Questionnaire a, Food Frequency Questionnaire b completed with telephone interviewer, brief assessment tools, and 4 dietary records of 3 days each distributed throughout the year will be used.
- Conditions
- Ischemic Heart Disease, Coronary Heart Disease
- Keywords
- Metabolomics, Mediterranean Diet, Ischemic Heart Disease, Food Patterns, Dietary Assessment Methods
- Medical subject headings
- Myocardial Ischemia, Coronary Disease
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 |
|---|---|---|
| Control Group | Six hundred volunteers. This group has to be without any type of cardiovascular Disease. | |
| Case Group | Six hundred volunteers. In this group, participants must present a diagnosis of ischemic heart disease at least 1 year but less than 5 years from recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomics
Human plasma and serum will be analysed to obtain chemical information of the different families of metabolites.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start19 Dec 2022
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pilar Buil- Cosiales, Doctor, Principal investigator, Servicio Navarro de Salud - Osasunbidea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706519
- Sponsor's protocol ID
- PMP21/00125
- Acronym
- OMIC-CARD
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics, Genomics and Nutrition for Cardiovascular Disease Precision Medicine
- ClinicalTrials.gov ID
- NCT05706519
- Acronym / sponsor ID
- OMIC-CARD / PMP21/00125
- Conditions
- Ischemic Heart Disease, Coronary Heart Disease
- Keywords
- Metabolomics, Mediterranean Diet, Ischemic Heart Disease, Food Patterns, Dietary Assessment Methods
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 31 Jan 2023 (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 objective of this project is to validate, through high-throughput advanced metabolomics techniques, the nutritional assessment tools to be used in the IMPaCT cohort. At the same time, the ability of metabolomics fingerprints of nutritional patterns to discriminate between patients with and without major cardiovascular disease will be identified. Finally, the modification of these predictions will be evaluated based on the genetic profiles. The main hypothesis holds that the integration of metabolomics, genomic and nutritional information will serve to personalize the approach to cardiovascular disease, both in prevention and treatment, and that these tools, in turn, will be valid enough to be applied systematically and efficiently in the IMPaCT cohort.
Detailed description
In two independent samples, one of 600 subjects free of cardiovascular disease (control group) and the other of 600 subjects with a history of ischemic heart disease (established heart disease group) eating habits will be evaluated using Food Frequency Questionnaire, based on those repeatedly used in epidemiological studies carried out in Spain, as well as other nutritional evaluation tools. Each participant will undergo a complete plasma metabolomics profile with identification of > 300 metabolites and a complete genome-wide association analysis. Artificial intelligence models and elastic net regression self-learning algorithms will be applied to select the metabolomics fingerprint of eating patterns.
The objectives are:
- To assess whether the relationship between diet and metabolic footprint is similar in those with established Cardio Vascular Disease or not. This will allow evaluating the usefulness of metabolic fingerprint to monitor the metabolic response to diet in patients with Cardio Vascular Disease and thus help to individualize their pharmacological and non-pharmacological treatment (diet and lifestyle)
- If there are sociodemographic characteristics - including the gender perspective-, clinical or genetic characteristics that help identify people who present a greater metabolic response to diet both in people without and in people with Cardio Vascular Disease.
- If the possible limitations of the metabolic footprint of different dietary patterns are reduced by using different tools for the collection of nutritional information. Self -completed Food Frequency Questionnaire a, Food Frequency Questionnaire b completed with telephone interviewer, brief assessment tools, and 4 dietary records of 3 days each distributed throughout the year will be used.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Six hundred volunteers. This group has to be without any type of cardiovascular Disease. |
| Case Group | – | –Six hundred volunteers. In this group, participants must present a diagnosis of ischemic heart disease at least 1 year but less than 5 years from recruitment |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Six recruitment nodes were established, each one from a different Autonomous Community (Andalusia, Cantabria, The Balearic Islands, Madrid, Navarra, and the Basque Country), Comprising cardiologist and primary care clinicians. In each of the 6 nodes, 100 participants without ischemic heart disease (ICD) will be recruited for the control group and another 100 for the case group. The controls will be selected through the health Centers, The cases will be selected in CS and in Cardiology consultations of the National Health Service (NHS).
Key inclusion criteria (9 listed)
- Age between 50 - 79 years old
- Living in Spain for more than 2 years
- Fluent in Spanish
- Ability for answer all the study questionaries'
- Ability to validly grant informed consent
Key exclusion criteria (5 listed)
- Chronic alcoholism or regular alcohol consumption > 80 g/d
- BMI >40 kg/m²
- Participation in a clinical trial conducted with drugs or use of any drug in experimental status during the year prior to inclusion
- Patient with cancer treatment two years before
- Patient with history of gastrectomy or intestinal resection. Patients with acute infection or inflammatory process (e.g. Pneumonia), may be included in the study three months after the infectious process.
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
Metabolomics
Time frame: Baseline
Human plasma and serum will be analysed to obtain chemical information of the different families of metabolites.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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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.
Pilar Buil- Cosiales, Doctor principal investigator
Servicio Navarro de Salud - Osasunbidea
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Coronary Heart Disease, run by Fundacion Miguel Servet at 6 sites in Spain.
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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pilar Buil-Cosiales, Doctor (948290480, pilar.buil.cosiales@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomics (time frame: Baseline). 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 3 Feb 2023.