OMIC-CARD: Metabolomics, Genomics and Nutrition for Cardiovascular Disease Precision Medicine

Sponsor

Fundacion Miguel Servet (Other)

Overall Status

Recruiting

CT.gov ID

NCT05706519

Collaborator

(none)

1,200

Enrollment

Locations

16.4

Anticipated Duration (Months)

200

Patients Per Site

12.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease Coronary Heart Disease

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1200 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Metabolomics, Genomics and Nutrition for Cardiovascular Disease Precision Medicine

Actual Study Start Date :

Dec 19, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Metabolomics [Baseline]
Human plasma and serum will be analysed to obtain chemical information of the different families of metabolites.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ibs.GRANADA	Granada	Andalucia	Spain	18012
2	Instituto de Investigación Sanitaria	Vitoria	Araba	Spain	01009
3	Universidad de Cantabria	Santander	Cantabria	Spain	39011
4	Institut D' Investigació Sanitària Illes Balears	Palma De Mallorca	Illes Balears	Spain	07122
5	Servicio Navarro de Salud Osasunbidea	Pamplona	Navarra	Spain	31006
6	UAM	Madrid		Spain	28029