Chlamydia and Mycoplasma in Coronary Artery Disease - Full Text View

Purpose

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

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

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Prevalence of Chlamydia Pneumoniae and Mycoplasma Pneumoniae in Different Forms of Obstructive Coronary Artery Disease

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Chlamydia Infections Coronary Artery Disease Pneumonia

U.S. FDA Resources

Further study details as provided by Hospital de Base:

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. [ Time Frame: 6 months ]

Biospecimen Retention: Samples Without DNA

Blood sample - serum

Enrollment:	138
Study Start Date:	March 2002
Study Completion Date:	November 2004

Groups/Cohorts	Assigned Interventions
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).

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561028

Sponsors and Collaborators

Hospital de Base

University of Sao Paulo

Investigators

Study Director:

Jose C Nicolau, MD, pHD

University of Sao Paulo

More Information

No publications provided by Hospital de Base

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Maia IL, Nicolau JC, Machado Mde N, Maia LN, Takakura IT, Rocha PR, Cordeiro JA, Ramires JA. Prevalence of Chlamydia pneumoniae and Mycoplasma pneumoniae in different forms of coronary disease. Arq Bras Cardiol. 2009 Jun;92(6):405-11, 422-8, 439-45. English, Multiple languages.

ClinicalTrials.gov Identifier:	NCT00561028 History of Changes
Other Study ID Numbers:	5105/2001, 885/02
Study First Received:	November 19, 2007
Last Updated:	November 19, 2007
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Base:

Atherosclerosis
Coronary artery disease
Chlamydia pneumoniae
Mycoplasma pneumoniae

Additional relevant MeSH terms:

Atherosclerosis
Chlamydia Infections
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Pleuropneumonia
Mycoplasma Infections
Pneumonia, Mycoplasma
Pneumonia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Chlamydiaceae Infections
Gram-Negative Bacterial Infections

Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections
Pneumonia, Bacterial
Antibodies

ClinicalTrials.gov processed this record on May 16, 2013