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Completed

NCT Number: NCT01939912

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Wroclaw, 50-981, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adenosine

Drug

Antiarrhythmic agent.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Noblewell

Industry

Collaborators

  • Cibiem, Inc.

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2013
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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