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ClinicalTrials.gov ID

NCT05706519

Lead Sponsor

Fundacion Miguel ServetOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

1,200Estimated

Last Update Posted

Feb 3, 2023Actual

Start Date

Dec 19, 2022Actual

Primary Completion Date

May 2024Estimated

Completion Date

May 2024Estimated

Official Title

Metabolomics, Genomics and Nutrition for Cardiovascular Disease Precision Medicine

Brief 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 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.

• Ischemic Heart Disease
• Coronary Heart Disease

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

• 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
• 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.

Exclusion Criteria:

• 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.

Observational Model

Case-Control

Time Perspective

Cross-Sectional

Lead Sponsor

Fundacion Miguel ServetOTHER

mercedes.sotos@uam.es914975442