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Chlamydia and Mycoplasma in Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT00561028
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : November 20, 2007
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by:
Hospital de Base

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

Condition or disease Intervention/treatment
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 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 : March 2002
Actual Study Completion Date : November 2004


Group/Cohort 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).



Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
Blood sample - serum


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Group 1 and 2 - selected after admission in coronary care unit. Group 3 - selected from out-patient cardiology clinic. Group 4 - selected from the blood donation unit.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561028


Sponsors and Collaborators
Hospital de Base
University of Sao Paulo
Investigators
Study Director: Jose C Nicolau, MD, pHD University of Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00561028     History of Changes
Other Study ID Numbers: 5105/2001
885/02
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: November 20, 2007
Last Verified: November 2007

Keywords provided by Hospital de Base:
Atherosclerosis
Coronary artery disease
Chlamydia pneumoniae
Mycoplasma pneumoniae

Additional relevant MeSH terms:
Infection
Communicable Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Pneumonia
Atherosclerosis
Chlamydia Infections
Pleuropneumonia
Mycoplasma Infections
Pneumonia, Mycoplasma
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Pleurisy
Pleural Diseases
Mycoplasmatales Infections
Pneumonia, Bacterial