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Trial record 52 of 1195 for:    Adenosine

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

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


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

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.




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939912


Locations
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Poland
Centrum Chorób Serca - Klinika Kardiologii, 4. Wojskowy Szpital Kliniczny
Wroclaw, Poland, 50-981
Sponsors and Collaborators
Noblewell
Cibiem, Inc.
Investigators
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Principal Investigator: Piotr Ponikowski, Prof. 4. Wojskowy Szpital Kliniczny we Wroclawiu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Noblewell
ClinicalTrials.gov Identifier: NCT01939912     History of Changes
Other Study ID Numbers: ADENOSINE-PILOT-CIBIEM
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Adenosine
Hypersensitivity
Immune System Diseases
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