Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT06102993
Eligibility Criteria:
Patients with stable phase COPD (not exacerbated) diagnosed according to GesePOC criteria (Spanish guidelines of COPD), over 40 years of age (patients with a history of smoking and forced spirometry after a BD test with a quotient of 0.7) will be included. These patients may or may not have clinical atherosclerosis with/without CCV risk factors and will be studied globally and in groups. The group of acute COPD will consist of patients who have been admitted to the pneumology service diagnosed with exacerbation of COPD syndrome. They must have been diagnosed with COPD according to the GesEPOC (Spanish guidelines of COPD) criteria prior to admission. The control group will consist of 30-40 active smoking volunteers or former smokers without COPD matched by age, level of smoking, without respiratory or renal diseases or serious chronic conditions (severe, known HF, malignant diseases in progression...). COPD will be ruled out by spirometry and the rest of
the pathology will be ruled out by means of a clinical interview and review of ancient history. Stable-phase COPD who have renal failure (Glomerular filtration estimated by the CDK-EPI formula of less than 60 ml/min/1.73 m2), stable phase COPD who have undergone respiratory rehabilitation for at least 6 months before entering the study, or COPD in a stable phase with other diseases or drugs that may cause alterations in the parameters studied (specifically: active tumor diseases, sepsis, critical situations from another origin) will be excluded. Although a group of patients with iron deficiency anemia or iron deficiency without anemia will be included, we do not expect MIFRP to have prognostic utility in this group, so patients with iron deficiency anemia will be excluded from the prospective part of the study, according to the work of Pérez-Peiró et al. (11).
Patients in the COPD group in the stable phase will be followed for one year in outpatient pneumology clinics. During the follow-up, all researchers related to the follow-up will not know the results of the blood samples. During this time, patients with respiratory exacerbation will go to the Emergency Department freely, and a team of doctors not related with the study will decide whether or not to hospitalize patients according to their own clinical criteria.
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
100 Years
Study:
NCT06102993
Study Brief:
Protocol Section:
NCT06102993