NCT03062683

Brief Summary

The investigators compared the serum lactate, serum prolactin and serum creatine kinase concentrations following convulsive and non-convulsive syncopes. The aim of the study was to investigate their importance as diagnostic markers in transient loss of consciousness.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

March 6, 2017

Status Verified

February 1, 2017

Enrollment Period

12 months

First QC Date

February 20, 2017

Last Update Submit

March 3, 2017

Conditions

SyncopeLactate Blood Increase

Keywords

lactatesyncope

Outcome Measures

Primary Outcomes (1)

  • Comparison of the first measurements of serum lactate concentrations in blood samples between patients admitted with either a convulsive or a non-convulsive syncope

    2 hours

Secondary Outcomes (5)

  • Comparison of the first measurements of serum prolactin concentrations in blood samples between patients admitted with either a convulsive or a non-convulsive syncope

    2 hours

  • Comparison of the first measurements of creatine kinase concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope

    2 hours

  • Comparison of the first measurements of pH value concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope

    2 hours

  • Comparison of the first measurements of bicarbonate concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope

    2 hours

  • Comparison of the first measurements of sodium and potassium concentrations in blood samples between patients with either a convulsive or a non-convulsive syncope

    2 hours

Study Arms (2)

Non-convulsive syncope patients

Patients with a non-convulsive syncope triggered by a tilting table examination and whose serum lactate, prolactin and creatine kinase conc. in blood samples had been measured after the event.

Other: Lactate, prolactin and creatine kinase conc.

Convulsive syncope patients

Patients with a convulsive syncope triggered by a tilting table examination and whose serum lactate, prolactin and creatine kinase conc. in blood samples had been measured after the event.

Other: Lactate, prolactin and creatine kinase conc.

Interventions

Lactate, prolactin and creatine kinase conc.OTHER

Lactate, prolactin and creatine kinase conc. in blood samples were measured

Convulsive syncope patientsNon-convulsive syncope patients

Eligibility Criteria

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

cardiological patients with syncopes

You may qualify if:

  • Patients with convulsive or non-convulsive syncopes
  • years or older

You may not qualify if:

  • Prisoner
  • Age \< 18 years old
  • Lack of capacity for consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology/Department of Cardiology, University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52070, Germany

RECRUITING

Related Publications (1)

  • Matz O, Zdebik C, Zechbauer S, Bundgens L, Litmathe J, Willmes K, Schulz JB, Dafotakis M. Lactate as a diagnostic marker in transient loss of consciousness. Seizure. 2016 Aug;40:71-5. doi: 10.1016/j.seizure.2016.06.014. Epub 2016 Jun 23.

    PMID: 27367837BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

repeated blood samples (2-5 ml)

MeSH Terms

Conditions

SyncopeHyperlactatemia

Interventions

Lactic AcidProlactin

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic ChemicalsGonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Oliver Matz, Dr.

    RWTH Aachen University Hospital

    STUDY DIRECTOR

Central Study Contacts

Oliver Matz, Dr.

CONTACT

00492418080954omatz@ukaachen.de

Anne Cornelissen, Dr.

CONTACT

0049241800acornelissen@ukaachen.de

Study Design

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

Study Record Dates

First Submitted

February 20, 2017

First Posted

February 23, 2017

Study Start

January 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

March 6, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)