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Completed

NCT Number: NCT03158532

Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin

The radial approach for a coronary angiography has became popular in several centers because of its simplicity and fewer complications. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. Several strategies have been used to decrease the incidence of RAO (heparin, patent hemostasis, etc). Nitrates in intra-arterial have been widely studied in prevention of this spasm. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of RAO. The hypothesis that use of nitroglycerin at the start of catheterization would have the same effect was not tested.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitário Professor Polydoro Ernani de São Thiago, Florianópolis, Santa Catarina, Brazil

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About this study

Transradial access (TRA) has been increasingly adopted for diagnostic and interventional cardiovascular procedures in many centers worldwide. This is largely driven by the evidence supporting an unequivocal reduction in access site-related complications associated with TRA compared with transfemoral access, as well as reduction in cost and increased patient comfort. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. RAO is the most commun complication of transradial access, and its incidence continues to reach up to 12%.

Nitrates in intra-arterial have been widely studied in prevention of this spasm. Nitroglycerin binds to the surface of endothelial cells and undergoes two chemical reductions to form nitric oxide (NO). The nitric oxide then moves out of the endothelial cell and into an adjacent smooth muscle cell, where it promotes the formation of cyclic guanosine monophosphate (cGMP), which then promotes muscle relaxation. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of radial artery occlusion.

A big sheath to artery size ratio could reduce the incidence of RAO, so the main objective of this study is to evaluate whether administration of nitroglycerin at the start of a transradial procedure may preserve the patency of the radial artery; as well, confirm if nitroglycerin administration just before sheet removal helps to keep the radial artery patency.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for cardiac catheterization;
  • Suitable candidates for transradial approach;
  • Use of 5 or 6 French sheath in the procedure;
  • Signed informed consent.

Exclusion criteria

  • Unable to tolerate nitrates or known allergy to nitrates;
  • Use of any nitrate, by any route of administration, up to 1 hour before the procedure;
  • ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;
  • Intubated patients (on mechanical ventilation);
  • Complications before or during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke);
  • Prior inclusion in this trial.

Treatment and study plan

Nitroglycerin I

Drug

500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.

Other names: Tridil

Placebo I

Drug

Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.

Other names: Saline

Nitroglycerin II

Drug

500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

Other names: Tridil

Placebo II

Drug

Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

Other names: Saline

Primary outcomes

  1. Radial Artery Occlusion

    Time frame: 2 to 24 hours after procedure

    Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound

Secondary outcomes

  1. Late Radial Artery Occlusion

    Time frame: 30 days after procedure

    Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound

  2. Pain Assessment

    Time frame: up to 24 hours after procedure

    Pain felt by the patient in the forearm, assessed using numeric pain rating scale ranging from 0 to 10, 0 best (no pain) 10 worst (unbearable pain)

  3. Spasm (Operator Evaluation)

    Time frame: During the realization of the procedure

    Catheter friction, as experienced by the operator (subjective measure), during the realization of the procedure

  4. Procedure Duration

    Time frame: Duration of the procedure

    Total duration of the procedure in seconds, from puncture to haemostatic dressing.

  5. Radiation Exposure

    Time frame: During the procedure

    Total radiation used in the procedure

Sponsors and collaborators

Lead sponsor

Instituto de Cardiologia de Santa Catarina

Other

Registry information

Acronym: Patens

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 18, 2017
Registry last updated
Dec 9, 2024

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

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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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