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
  Purpose

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.


Condition
Coronary Artery Disease
Atheroscleroses
COPD
Respiratory Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Disease in Patients Referred for Coronary CT and Association Between Spirometric Abnormalities and Coronary Calcium Score.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Smoking Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    All endpoints will be evaluated in smoking and nonsmoking subgroups.


Biospecimen Retention:   Samples Without DNA

Blood Samples


Enrollment: 205
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coronary CT Spirometry Cohort
Patients refereed to coronary CT enrolled in the study.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734629

Locations
Brazil
Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Sao Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Alberto Cukier, MD PHD Incor - HCFMUSP
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01734629     History of Changes
Other Study ID Numbers: 2011/02814-0 FAPESP, 0503/11
Study First Received: November 21, 2012
Last Updated: November 26, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
Coronary Disease
COPD
Spirometry
Coronary tomography

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on July 28, 2014