The Effect of Peri-percutaneous Coronary Intervention Oxygenation on Myocardial Protection & Cardiovascular Fitness

NCT03256175 | Completed

• 1 other identifier: 1198.49
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Elective percutaneous coronary intervention (PCI) is often associated with myocardial necrosis evidenced by peri-procedural troponin release. This is a surrogate for subsequent cardiovascular events. There is no study on the effect of peri-PCI oxygenation in in myocardial protection and cardiopulmonary fitness outcome. Patients with higher baseline cardiopulmonary fitness will have lower mortality. This study is to assess the utility of oxygen to reduce ischaemia in patients with significant stable coronary artery disease scheduled for elective PCI. The secondary objective is to evaluate further effect of peri- PCI oxygenation on cardiovascular fitness and autonomic response.

Conditions

Myocardial Ischemia; Cardiovascular Morbidity

Keywords

Myocardial Protection; Oxygen; Exercise Test

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study was to assess the myocardial protection

  this is done by comparing changes Troponin I at 6 (baseline) to 24 hours between both study arms.

  6 hours and 24 hours after the procedure

Secondary Outcomes (3)

• To assess the utility of peri-PCI oxygenation to improve cardiovascular fitness

  6 weeks post procedure

• To assess the utility of peri-PCI oxygenation to improve autonomic response

  6 weeks post procedure

• To assess the utility of peri-PCI oxygenation to improve autonomic response

  6 weeks post procedure

Study Arms (2)

Oxygen

EXPERIMENTAL

Patient was give 15L/min of Oxygen via HFM 30 mins before and continue through out the procedure. 6 weeks post procedure, EST was arranged

Procedure: Percutaneous Coronary Intervention

Air

PLACEBO COMPARATOR

Patient was given Facemask without oxygen through out the procedure. 6 weeks post procedure, EST was arranged

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention PROCEDURE

PCI technique (e.g. pre-dilatation vs. direct stenting and stent choice) was left to operator discretion. Stent post dilatation was permitted as per individual operator practice

Air; Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>18 years
• Haemodynamically important coronary artery disease (\>70% luminal stenosis angiographically in ≥1 major epicardial coronary artery

You may not qualify if:

• Significant chronic airways disease with type-2 respiratory failure precluding safe use of oxygen
• Coronary stenoses where evidence of plaque instability is evident e.g. rest pain, visual evidence of thrombus, elevation of Troponin T at baseline

Sponsors & Collaborators

• University of Malaya: lead

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Soo Chin Chan, MBBS

  schin1022@yahoo.com

  PRINCIPAL INVESTIGATOR

• Anwar Suhami, MBBS

  anwar@ummc.edu.my

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both medical air and oxygen were supplied in compressed liquid form and available throughout the hospital. During the study, the medical gas cylinders shielded using an opaque temporary cover. Similarly the oxygen saturation was not displayed, but instead monitored by an independent third party.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 21, 2017
• Study Start: July 1, 2015
• Primary Completion: December 31, 2015
• Study Completion: June 30, 2016
• Last Updated: October 25, 2017

Record last verified: 2017-10