Clinical Trials Logo

Clinical Trial Summary

Cardiovascular diseases are the main cause of death in industrialized countries. Among them, atherosclerosis has the highest prevalence and constitutes a common pathological pathway responsible for the majority of cases of chronic ischemic heart disease, acute myocardial infarction, heart failure and cerebrovascular disease. Classic studies have confirmed well-established etiopathogenic factors of atherosclerosis based on genetic and immunological components and environmental modifying agents such as diet and exercise. But in addition, recent experimental studies have shown that dysbiosis (alteration of the microbiota) may be an additional factor that participates in the onset and progression of atherosclerosis. The objective of this study is to identify the potential interactions between changes in the microbiota, changes in the immune status, the clinical evolution and the instability and progression of atherosclerosis.


Clinical Trial Description

The study will prospectively study two groups of patients : 1) patients with acute coronary syndrome and 2) age and sex matched patients with chronic stable documented atherosclerosis. Immune cell populations and immune-related metabolites will be characterized, the genetic profile of the main known functional variants will be determined, and the oral, gastrointestinal, and blood microbiota will be compared in both groups in a transversal observational design. In addition, 1-year clinical follow-up will be performed and correlation with the evolution of the microbiota and immune response in a longitudinal design will be conducted. Besides, an angiographic substudy, for those patients included in the study but that require revascularization of culprit artery according to clinical indication, will be 1 year follow-up and functional assessment and intravascular imaging and the degree of remodelling of the atherosclerotic plaque will be correlated with the evolution of the microbiota and immune response in a longitudinal design. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03434483
Study type Observational [Patient Registry]
Source Hospital General Universitario Gregorio Marañon
Contact
Status Completed
Phase
Start date February 25, 2018
Completion date February 8, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT05412927 - AngelMed Guardian® System PMA Post Approval Study
Completed NCT02750579 - Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes? N/A
Completed NCT04102410 - Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients N/A
Enrolling by invitation NCT03342131 - Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome N/A
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Enrolling by invitation NCT04676100 - International CR Registry
Completed NCT03590535 - 5th Generation cTnT in ED ACS
Recruiting NCT05437900 - INSIGHTFUL-FFR Clinical Trial Phase 4
Completed NCT05551429 - Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Terminated NCT04316481 - IDE-ALERTS Continued Access Study N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT04852146 - Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
Active, not recruiting NCT02892903 - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? N/A
Completed NCT04077229 - Piloting Text Messages to Promote Positive Affect and Physical Activity N/A
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Completed NCT02944123 - Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR) Phase 3
Active, not recruiting NCT02922140 - The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit N/A
Completed NCT02673437 - Rivaroxaban ACS Specialist Cohort Event Monitoring Study