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

Not Applicable

Completed

• Conditions: Heart Failure; Peripheral Chemoreceptor Hypersensitivity
• Interventions: Drug: Adenosine

• Registration Number: NCT01939912
• Lead Sponsor: Noblewell

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-11
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stimulation of carotid body chemoreceptors	Adenosine	Adenosine boluses will be administered through an intravascular catheter used to administer the contrast agent during the carotid artery arteriography.

Primary Outcome Measures

Name	Time	Method
Arterial blood pressure	30 minutes	Assessment of the adenosine influence on the monitored parameter
Ventilation at rest	30 minutes	Assessment of the adenosine influence on the monitored parameter

Secondary Outcome Measures

Name	Time	Method
ECG	30 minutes	Assessment of the adenosine influence on the monitored parameter
Breathing pattern	30 minutes	Assessment of the adenosine influence on the monitored parameter
Capillary blood saturation	30 minutes	Assessment of the adenosine influence on the monitored parameter

Trial Locations

Locations (1)

Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny; 🇵🇱 Wroclaw, Poland