NCT02111733

Brief Summary

Evaluation of High sensibility troponin levels modification by hemodialysis in terminal renal failure patient at Sherbrooke University Hospital Center as determined by serial measurements. Verification of potential effects of these levels and their variation as predictors of cardiovascular outcomes and events at 6 and 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

June 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

3 months

First QC Date

December 10, 2013

Last Update Submit

April 8, 2014

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

  • High sensibility troponins T blood level variation

    Verification of high sensibility troponins T blood after classical hemodialysis compared to pre-treatment levels.

    1 week

Secondary Outcomes (1)

  • Prognostic value of high sensibility troponins T blood level variation

    at 6 and 12 months

Study Arms (1)

Hs-TnT

EXPERIMENTAL

Hs-TNT dosage

Other: Hs-TNT dosage

Interventions

Hs-TNT dosageOTHER

Bloodwork before and after hemodialysis for high sensibility troponins T blood level

Hs-TnT

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 50 years, no symptoms, over 1 months of hemodialysis

You may not qualify if:

  • or more in the last month; Acute coronary syndrome, Heart failure decompensated, Myo or Pericarditis, Pulmonary embolism, Sepsis/shock, Stroke or transient ischemic attack, Malignant high blood pressure, Arrythmia, electrical cardio-version, major trauma, significant burnings (\>25%), Chemotherapy, Cardiovascular surgery, percutaneous angio-intervention,
  • Chronic systemic disease (sarcoidosis, amyloidosis, LED, Etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

University of Sherbrooke

Sherbrooke, Quebec, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Michel Nguyen, MD

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

April 11, 2014

Study Start

June 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations

CA(2)