Study on Reflex Response During Temporary Stimulation and Inhibition of Chemoreceptors of Carotid Bodies - a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Peripheral Chemoreceptor Hypersensitivity
• Intervention / Treatment: Drug: Adenosine

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Wroclaw, Poland, 50-981
    • Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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;
• stable clinical condition for at least 4 weeks prior to the inclusion in the study;
• over 18 years of age;
• ability to give and giving the informed consent to participate in the study.

Exclusion Criteria:

• bilateral significant carotid artery stenosis;
• complete closure or critical constriction of either of the carotid arteries;
• brain stroke or transient ischaemic attack (TIA) within 6 months prior to the inclusion in the study;
• unstable angina pectoris, coronary attack within 3 months prior to the inclusion in the study;
• coronary revascularisation or clinically significant infection within 1 month prior to the inclusion in the study;
• 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;
• patients undergoing haemodialysis or peritoneal dialysis at inclusion in the study;
• 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;
• stage III (Fontaine) obliterative arteriosclerosis of the lower limb and/or Buerger's disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulation of carotid body chemoreceptors; Adenosine boluses will be administered through an intravascular catheter used to administer the contrast agent during the carotid artery arteriography.	Drug: Adenosine; Antiarrhythmic agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG	Assessment of the adenosine influence on the monitored parameter	30 minutes
Capillary blood saturation	Assessment of the adenosine influence on the monitored parameter	30 minutes
Breathing pattern	Assessment of the adenosine influence on the monitored parameter	30 minutes

Collaborators and Investigators

• Sponsor: Noblewell
• Collaborators: Cibiem, Inc.
• Investigators: Principal Investigator: Piotr Ponikowski, Prof., 4. Wojskowy Szpital Kliniczny we Wroclawiu

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: September 6, 2013
• First Posted (Estimate): September 11, 2013

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine
• Other Study ID Numbers: ADENOSINE-PILOT-CIBIEM