Chlamydia and Mycoplasma in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Prevalence of Chlamydia Pneumoniae and Mycoplasma Pneumoniae in Different Forms of Obstructive Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561028
• Other study ID #: 5105/2001
• Secondary ID: 885/02
• Status: Completed
• Phase: N/A
• First received: November 19, 2007
• Last updated: November 19, 2007
• Start date: March 2002
• Est. completion date: November 2004

Study information

• Verified date: November 2007
• Source: Hospital de Base
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

To test the association between anti-Chlamydia serum titers and anti-Mycoplasma antibodies with Acute Coronary Syndromes.

Description:

One hundred and twenty-six patients were divided into 4 groups: Acute Coronary Syndrome with ST-elevation, Non-ST-elevation, stable coronary artery disease, and individuals without coronary disease. Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured at baseline and after 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: November 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 yrs

• Males and females

• Agreed to sign the informed consent

Exclusion Criteria:

• Refusal to sign the informed consent

• Follow-up not possible

• For the "acute" groups, time between the pain beginning and randomization >24 hours

• Active infections

• Use of antimicrobial agents within the last 30 days

• End-stage diseases with life expectancy <6 months

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Chlamydia Infections
• Coronary Artery Disease
• Coronary Disease
• Infection
• Mycoplasma Infections
• Myocardial Ischemia
• Pleuropneumonia
• Pneumonia, Mycoplasma

Intervention

Other:
• blood sample analysis - mycoplasma and chlamydia antibodies
Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured by indirect immunofluorescence at baseline (24 hours of hospitalization) and after 6 months (follow-up).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Base	University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test the hypothesis that patients with acute coronary syndromes have higher levels of Chlamydia pneumonia and Mycoplasma pneumonia antibodies in comparison with patients with stable coronary artery disease or controls.		6 months