Pulmonary Disease in Patients Referred for Coronary CT

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01734629
First received: November 21, 2012
Last updated: November 26, 2013
Last verified: November 2013

November 21, 2012
November 26, 2013
April 2011
December 2013   (final data collection date for primary outcome measure)
Coronary Calcium Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Coronary calcium score is a measurement obtained in coronary computer tomography. The results will be compared between group with and without spirometric abnormalities.
Same as current
Complete list of historical versions of study NCT01734629 on ClinicalTrials.gov Archive Site
  • Coronary obstruction on CT [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Presence or absence of coronary obstruction and it´s quantification by Duke score will be compared between group with and without spirometric abnormality.
  • Hospital Admissions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Hospital admissions will be accessed after one year from enrollment and compared between groups
  • ER visits [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    ER visits will be accessed after one year from enrollment and compared between groups
  • Fatal and non fatal cardiac or respiratory events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Fatal and non fatal cardiac or respiratory events will be accessed after one year from enrollment and compared between groups
Same as current
Smoking Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
All endpoints will be evaluated in smoking and nonsmoking subgroups.
Same as current
 
Pulmonary Disease in Patients Referred for Coronary CT
Pulmonary Disease in Patients Referred for Coronary CT and Association Between Spirometric Abnormalities and Coronary Calcium Score.

Several studies show an association between chronic obstructive pulmonary disease (COPD) and coronary artery disease (CAD). Besides risk factors such as smoking, both are associated with physical inactivity, advanced age and systemic inflammation The use of coronary computed tomography (CCT) with multiple detectors is a diagnostic method for coronary disease, describing the anatomy and severity of arterial obstruction. One way of estimating the cardiovascular risk is coronary calcium score (CCS). Due to the association between COPD and CAD, it is likely that many patients with IHD diagnosed by CT have reduced lung function.

The aim of this observational study is to establish the correlation between the CCS and lung function. It will also correlate the presence of irreversible airway obstruction with significant coronary lesions.

Patients over 40 years referred to CCT who agree to participate in the study will perform a spirometry with bronchodilator and collect a blood sample to measure serum markers of inflammation and cardiovascular risk (glycemia, lipid profile, C reactive protein (CRP), tumor necrosis factor-alpha (TNF-Alpha) and fibrinogen). The data will be compared in the general population and in subgroups: smokers, former smokers and nonsmokers.

One year after the CCT patients will be contacted by the investigators and accessed for emergency room visits, hospital admissions and fatal or nonfatal coronary or respiratory events.

The investigators hypothesis is that reduced lung function is independently associated with elevated CCS and is, also a risk factor for increased hospital admission and coronary events.

The concomitant assessment of lung function and CCS can contribute knowledge about the epidemiological association between pulmonary disease and CAD. This can also add to evidence for the use of spirometry as a marker of cardiovascular risk.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood Samples

Non-Probability Sample

Patients over 40 years old refereed to coronary CT in the investigator´s institution.

  • Coronary Artery Disease
  • Atheroscleroses
  • COPD
  • Respiratory Diseases
Not Provided
Coronary CT Spirometry Cohort
Patients refereed to coronary CT enrolled in the study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
205
December 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients referred for coronary CT.
  • Age greater than 40 years

Exclusion Criteria:

  • History of myocardial revascularization (surgical or percutaneous)
  • Cognitive-functional incapacity to perform spirometry
  • Contraindication for administration of 400 mcg of albuterol
  • Acute myocardial infarction or unstable angina within 2 weeks
  • Angina pectoris class III or IV according to the Canadian Cardiovascular Society
  • Heart failure New York Heart Association class III or IV
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01734629
2011/02814-0 FAPESP, 0503/11
Yes
University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Not Provided
Principal Investigator: Alberto Cukier, MD PHD Incor - HCFMUSP
University of Sao Paulo General Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP