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

Primary Purpose

Heart Failure, Peripheral Chemoreceptor Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Adenosine
Sponsored by
Noblewell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stimulation of carotid body chemoreceptors

Arm Description

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

Outcomes

Primary Outcome Measures

Ventilation at rest
Assessment of the adenosine influence on the monitored parameter
Arterial blood pressure
Assessment of the adenosine influence on the monitored parameter

Secondary Outcome Measures

ECG
Assessment of the adenosine influence on the monitored parameter
Capillary blood saturation
Assessment of the adenosine influence on the monitored parameter
Breathing pattern
Assessment of the adenosine influence on the monitored parameter

Full Information

First Posted
August 29, 2013
Last Updated
October 14, 2016
Sponsor
Noblewell
Collaborators
Cibiem, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01939912
Brief Title
Study on Reflex Response During Temporary Stimulation and Inhibition of Chemoreceptors of Carotid Bodies - a Pilot Study
Official Title
Study on Reflex Response During Temporary Stimulation and Inhibition of Chemoreceptors of Carotid Bodies - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noblewell
Collaborators
Cibiem, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Peripheral Chemoreceptor Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stimulation of carotid body chemoreceptors
Arm Type
Experimental
Arm Description
Adenosine boluses will be administered through an intravascular catheter used to administer the contrast agent during the carotid artery arteriography.
Intervention Type
Drug
Intervention Name(s)
Adenosine
Intervention Description
Antiarrhythmic agent.
Primary Outcome Measure Information:
Title
Ventilation at rest
Description
Assessment of the adenosine influence on the monitored parameter
Time Frame
30 minutes
Title
Arterial blood pressure
Description
Assessment of the adenosine influence on the monitored parameter
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
ECG
Description
Assessment of the adenosine influence on the monitored parameter
Time Frame
30 minutes
Title
Capillary blood saturation
Description
Assessment of the adenosine influence on the monitored parameter
Time Frame
30 minutes
Title
Breathing pattern
Description
Assessment of the adenosine influence on the monitored parameter
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Ponikowski, Prof.
Organizational Affiliation
4. Wojskowy Szpital Kliniczny we Wroclawiu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27435894
Citation
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.
Results Reference
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Study on Reflex Response During Temporary Stimulation and Inhibition of Chemoreceptors of Carotid Bodies - a Pilot Study

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