NCT01939912

Brief Summary

The isolated response of the carotid bodies to local stimulation with adenosine has not been researched in humans. There are single reports indicating that intravenous administration of adenosine causes hyperventilation through activating the carotid bodies. Adenosine will be injected intraarterially during invasive treatment (percutaneous carotid artery stenting, CAS) or diagnostic (arteriography) procedures and their conduct will only slightly influence the standard scheme of the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

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

August 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

August 29, 2013

Last Update Submit

October 14, 2016

Conditions

Heart FailurePeripheral Chemoreceptor Hypersensitivity

Outcome Measures

Primary Outcomes (2)

  • Ventilation at rest

    Assessment of the adenosine influence on the monitored parameter

    30 minutes

  • Arterial blood pressure

    Assessment of the adenosine influence on the monitored parameter

    30 minutes

Secondary Outcomes (3)

  • ECG

    30 minutes

  • Capillary blood saturation

    30 minutes

  • Breathing pattern

    30 minutes

Study Arms (1)

Stimulation of carotid body chemoreceptors

EXPERIMENTAL

Adenosine boluses will be administered through an intravascular catheter used to administer the contrast agent during the carotid artery arteriography.

Drug: Adenosine

Interventions

AdenosineDRUG

Antiarrhythmic agent.

Stimulation of carotid body chemoreceptors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stenosis of one of the internal carotid arteries qualifying the patient to the procedure treatment (according to the ESC 2011 or American Heart Association (AHA) guidelines) or the necessity of the carotid artery arteriography, in order to verify the level of narrowing;
  • in the case of procedure treatment, patient's declaration to be treated by the percutaneous method;
  • over 18 years of age;
  • ability to give and giving the informed consent to participate in the study.

You may not qualify if:

  • bilateral significant carotid artery stenosis;
  • complete closure or critical constriction of either of the carotid arteries;
  • significant chronic neurological condition in medical history;
  • dipyridamole or theophyline-based medications taken by the patient;
  • bronchial asthma;
  • GOLD 3 or 4 Chronic Obstructive Pulmonary Disease (COPD) in medical history;
  • second or third degree atrioventricular block, sick sinus syndrome, or an additional evident track of atrioventricular conducting;
  • advanced first degree atrioventricular block (PQ \> 240 ms)
  • extension of the QTc interval \> 0.5 s;
  • grade 3 (ESC) arterial hypertension;
  • previously stated oversensitivity to adenosine;
  • pregnancy;
  • undergone heart transplantation;
  • any significant, in the investigator's assessment, aberrations detected in additional tests, increasing the risk related to performing procedures predicted by the protocol;
  • lack of informed consent for the participation in the study;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny

Wroclaw, 50-981, Poland

Location

Related Publications (1)

  • Tubek S, Niewinski P, Reczuch K, Janczak D, Rucinski A, Paleczny B, Engelman ZJ, Banasiak W, Paton JF, Ponikowski P. Effects of selective carotid body stimulation with adenosine in conscious humans. J Physiol. 2016 Nov 1;594(21):6225-6240. doi: 10.1113/JP272109. Epub 2016 Sep 11.

    PMID: 27435894DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Piotr Ponikowski, Prof.

    4. Wojskowy Szpital Kliniczny we Wroclawiu

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 11, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

PL(1)