Cardiovascular Diseases Clinical Trial
— ACAR1Official title:
Efficacy of Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity as a Biomarker of Myocardial Damage in Patients With Rheumatoid Arthritis With Severe Activity.
Verified date | August 2019 |
Source | Hospital Central "Dr. Ignacio Morones Prieto" |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pilot study. The primary end point is the evaluation the efficacy of treatment with atorvastatin compared to colchicine for the decrease of high sensitivity troponin I levels in patients with rheumatoid arthritis with severe activity according of the Disease Activity Score 28 (DAS 28> 5.1), through a randomized controlled clinical trial blinded to the rheumatologist and the cardiologist who will carry out the evaluation of the patient.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients older than 18 years with a diagnosis of rheumatoid arthritis according to the diagnoses of the American College of Rheumatology and the European League against rheumatism 2010 with severe disease activity according to DAS 28> 5.1. - Patients who are accepted according to previous criteria and with signed informed consent. Exclusion Criteria: - Patients with a history of ischemic heart disease. - Patients with a history of heart failure with decreased left ventricular ejection fraction - Patients with chronic kidney disease. |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Central "Dr Ignacio Morones Prieto" | San Luis Potosí |
Lead Sponsor | Collaborator |
---|---|
Hospital Central "Dr. Ignacio Morones Prieto" |
Mexico,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of high sensitivity troponin I levels | Levels of high sensitivity troponin I in ng / ml with the ARCHITECT STAT Troponin-I assay of high sensitivity by immunoassay by chemo luminescent microparticles, with a calibration range of 0.0-50,000.00 pg / ml. | It will be evaluated before the start of treatment and at the end of the four weeks of treatment. | |
Secondary | Changes in echocardiographic findings | Changes by echocardiography in patients with alterations found in the initial study after 4 weeks of treatment with a new imaging study. | It will be evaluated before the start of treatment and at the end of the four weeks of treatment. | |
Secondary | Risk factors associated with a higher elevation high sensitivity troponin I | Perform statistical analysis with the baseline characteristics of patients to show their association with high levels of high sensitivity troponin I. | It will be evaluated before the start of treatment |
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