NCT01727518

Brief Summary

The LEAD study is the first longitudinal cohort investigating respiratory, cardiac, and metabolic health in a reference population of Austria.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,966

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2011Oct 2028

Study Start

First participant enrolled

October 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

November 21, 2024

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Expected
Last Updated

December 17, 2024

Status Verified

November 1, 2024

Enrollment Period

5 years

First QC Date

November 4, 2012

Results QC Date

April 13, 2020

Last Update Submit

November 21, 2024

Conditions

Keywords

natural historylung functiongeneral populationmetabolic health

Outcome Measures

Primary Outcomes (1)

  • Abnormal Lung Function in the General Population

    Prebronchodilation (pre-BD) and post-BD forced spirometry measurements were determined according to international recommendations (ERS Global Lung Function Initiative). Abnromal lung function determined as forced expiratory volume in 1 second (FEV1) \< Lower Limit of Normal (LLN) or forced vital capacity (FVC) \< LLN or FEV1/FVC \< LLN.

    4 years

Study Arms (1)

Reference Population

No Intervention

Other: As the LEAD study is an observational cohort study, there is no intervention to report.

Interventions

As the LEAD study is an observational cohort study, there is no intervention to report.

Reference Population

Eligibility Criteria

Age6 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community based cohort

You may qualify if:

  • Male and Female,
  • Age 6 - 80 years,
  • Invitation by study invitation letter

You may not qualify if:

  • Insufficient language skills
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The LEAD Study Center

Vienna, 1140, Austria

Location

Related Publications (4)

  • Azizzadeh M, Karimi A, Danninger K, Breyer MK, Breyer-Kohansal R, Konig A, Kaufmann CC, Boutouyrie P, Bruno RM, Mayer CC, Jager B, Hartl S, Burghuber OC, Weber T. Prevalence and determinants of vascular aging in Austria - a holistic view: the LEAD study. J Hypertens. 2025 Dec 30. doi: 10.1097/HJH.0000000000004227. Online ahead of print.

  • Dal Grande A, Van Herck M, Breyer-Kohansal R, Mraz T, Karimi A, Azizzadeh M, Hartl S, Burghuber OC, Wouters EFM, Kautzky-Willer A, Schiffers C, Breyer MK. Incidence of Prediabetes and Diabetes in a European Longitudinal General Population Cohort and Its Associated Factors-Results From the Austrian LEAD Study. J Diabetes Res. 2025 Apr 22;2025:5540276. doi: 10.1155/jdr/5540276. eCollection 2025.

  • Kolli F, Breyer MK, Hartl S, Burghuber O, Wouters EFM, Sigsgaard T, Pohl W, Kohlbock G, Breyer-Kohansal R. Aero-Allergen Sensitization in the General Population: Longitudinal Analyses of the LEAD (Lung Heart Social Body) Study. J Asthma Allergy. 2022 Apr 11;15:461-473. doi: 10.2147/JAA.S349614. eCollection 2022.

  • Breyer-Kohansal R, Hartl S, Burghuber OC, Urban M, Schrott A, Agusti A, Sigsgaard T, Vogelmeier C, Wouters E, Studnicka M, Breyer MK. The LEAD (Lung, Heart, Social, Body) Study: Objectives, Methodology, and External Validity of the Population-Based Cohort Study. J Epidemiol. 2019 Aug 5;29(8):315-324. doi: 10.2188/jea.JE20180039. Epub 2018 Oct 20.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Samples of urine and blood

MeSH Terms

Conditions

Respiration DisordersGlucocorticoid Receptor Deficiency

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

Title
Dr Robab Breyer-Kohansal
Organization
Ludwig Boltzmann Institute for Lung Health

Study Officials

  • Robab Breyer-Kohansal, Prof. Dr.

    Ludwig Boltzmann Institute for Lung Health, Vienna, Austria

    PRINCIPAL INVESTIGATOR
  • Marie-Kathrin Breyer, Prof. Dr

    Ludwig Boltzmann Institute for Lung Health, Vienna, Austria

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2012

First Posted

November 16, 2012

Study Start

October 1, 2011

Primary Completion

October 1, 2016

Study Completion (Estimated)

October 1, 2028

Last Updated

December 17, 2024

Results First Posted

November 21, 2024

Record last verified: 2024-11

Locations