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

NCT ID: NCT01939912

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-09-30

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.

Conditions

Heart Failure; Peripheral Chemoreceptor Hypersensitivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Adenosine

Intervention Type: DRUG

Antiarrhythmic agent.

Interventions

Adenosine

Antiarrhythmic agent.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cibiem, Inc.

INDUSTRY

Sponsor Role: collaborator

Noblewell

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Ponikowski, Prof.

Role: PRINCIPAL_INVESTIGATOR

4. Wojskowy Szpital Kliniczny we Wroclawiu

Locations

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

Wroclaw, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 27435894 (View on PubMed)

Other Identifiers

ADENOSINE-PILOT-CIBIEM

Identifier Type: -

Identifier Source: org_study_id