NCT02563470

Brief Summary

In this retrospective registry trial, the investigators sought to assess the incidence and predictors of cardiovascular and cerebrovascular complications as well as their derivatives (acute coronary syndrome, decompensated heart failure, an episode of atrial fibrillation requiring cardiologist consultation, stroke, pulmonary embolism and venous thromboembolism) in cohort of patients undergoing head and neck surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
456

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Status
completed

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 Start

First participant enrolled

April 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

September 28, 2015

Last Update Submit

September 29, 2015

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (6)

  • all cause mortality

    5 years

  • myocardial infarction

    5 years

  • stroke

    5 years

  • bleeding

    30 days

  • decompensated heart failure

    5 years

  • new onset atrial fibrillation

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

head and neck cancer patients

You may qualify if:

  • patients diagnosed with head and neck cancer in Turku University hospital between 1999-2008

You may not qualify if:

  • skin cancer, treatment started in other institute or not finished in our institute

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Tuomas Kiviniemi, MD, PhD

    Turku University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist, MD, PhD

Study Record Dates

First Submitted

September 28, 2015

First Posted

September 30, 2015

Study Start

April 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 30, 2015

Record last verified: 2015-09