Chlamydia and Mycoplasma in Coronary Artery Disease

Sponsor

Hospital de Base (Other)

Overall Status

Completed

CT.gov ID

NCT00561028

Collaborator

University of Sao Paulo (Other)

138

Enrollment

32.1

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Coronary Artery Disease Chlamydia Infections Mycoplasma Infections	Other: blood sample analysis - mycoplasma and chlamydia antibodies

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

138 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2002

Actual Study Completion Date :

Nov 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
1 ST-elevation acute myocardial infarction.	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).
2 high-risk unstable angina or non-ST-elevation myocardial infarction.	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).
3 known coronary artery disease, either asymptomatic or with stable angina.	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).
4 blood donors without known coronary artery disease.	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).

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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