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

• ClinicalTrials.gov Identifier: NCT01939912
• Recruitment Status: Completed
• First Posted: September 11, 2013
• Last Update Posted: October 17, 2016
• Sponsor: Noblewell
• Collaborator: Cibiem, Inc.
• Information provided by (Responsible Party): Noblewell

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure; Peripheral Chemoreceptor Hypersensitivity	Drug: Adenosine	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study on Reflex Response During Temporary Stimulation and Inhibition of Chemoreceptors of Carotid Bodies - a Pilot Study
• Study Start Date: August 2013
• Actual Primary Completion Date: September 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Ventilation at rest [ Time Frame: 30 minutes ]
   Assessment of the adenosine influence on the monitored parameter
2. Arterial blood pressure [ Time Frame: 30 minutes ]
   Assessment of the adenosine influence on the monitored parameter

Secondary Outcome Measures :

1. ECG [ Time Frame: 30 minutes ]
   Assessment of the adenosine influence on the monitored parameter
2. Capillary blood saturation [ Time Frame: 30 minutes ]
   Assessment of the adenosine influence on the monitored parameter
3. Breathing pattern [ Time Frame: 30 minutes ]
   Assessment of the adenosine influence on the monitored parameter

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Poland

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

Wroclaw, Poland, 50-981

Sponsors and Collaborators

Noblewell

Cibiem, Inc.

Investigators

• Principal Investigator: Piotr Ponikowski, Prof.; 4. Wojskowy Szpital Kliniczny we Wroclawiu

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Noblewell
• ClinicalTrials.gov Identifier: NCT01939912
• Other Study ID Numbers: ADENOSINE-PILOT-CIBIEM
• First Posted: September 11, 2013
• Last Update Posted: October 17, 2016
• Last Verified: October 2016

Additional relevant MeSH terms:

Hypersensitivity; Immune System Diseases; Adenosine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Vasodilator Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action