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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939912
• Other study ID #: ADENOSINE-PILOT-CIBIEM
• Status: Completed
• Phase: N/A
• First received: August 29, 2013
• Last updated: October 14, 2016
• Start date: August 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Noblewell
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Hypersensitivity
• Peripheral Chemoreceptor Hypersensitivity

Intervention

Drug:
• Adenosine
Antiarrhythmic agent.

Locations

Country	Name	City	State
Poland	Centrum Choro´b Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Noblewell	Cibiem, Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilation at rest	Assessment of the adenosine influence on the monitored parameter	30 minutes	Yes
Primary	Arterial blood pressure	Assessment of the adenosine influence on the monitored parameter	30 minutes	Yes
Secondary	ECG	Assessment of the adenosine influence on the monitored parameter	30 minutes	No
Secondary	Capillary blood saturation	Assessment of the adenosine influence on the monitored parameter	30 minutes	No
Secondary	Breathing pattern	Assessment of the adenosine influence on the monitored parameter	30 minutes	No