Ischaemic Pre-Conditioning in Elective Percutaneous Coronary Intervention (PCI) Patients

NCT00765908 | Unknown Phase 1

• 1 other identifier: UHN 2008-1
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess the potential for ischaemic peri-conditioning (IP) in elective percutaneous coronary intervention (PCI) patients to attenuate ischaemia in an animal model of myocardial infarct.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Attenuation of infarct size and improved post-ischemia haemodynamic recovery in rat hearts.

  immediate

Secondary Outcomes (1)

• Clinical endpoints: (i) induction of IP, defined as a minimum 33% reduction in magnitude of ST segment deviation in the territory of the affected artery between the first and second balloon inflation. (ii) Reduction in CK rise post procedure.

  immediate

Study Arms (2)

A

EXPERIMENTAL

Patients undergoing elective PCI will be randomised to 90 second balloon inflations rather than the standard less than 30 second inflations in order to induce peri-ischaemic conditioning.

Device: Angioplasty balloon

B

ACTIVE COMPARATOR

Control group. These patients will have a standard procedure with balloon inflations of 30 seconds or less as per standard.

Device: Angioplasty balloon

Interventions

Angioplasty balloon DEVICE

90 second balloon inflation x 2

A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give written informed consent.
• All patients who are listed for elective PCI of at least one major epicardial artery.
• Patients ≥ 18 years and ≤80 years of age.

You may not qualify if:

• Any patient who has experienced chest pain within the preceding 24 hrs
• Any patient who exhibits haemodynamic instability (systolic BP \<90mmHg, pulmonary oedema);
• Any patient with electrophysiologic instability (arrythmias eg rapid AF) or an abnormal baseline electrocardiogram (ECG) (e.g., significant ST segment depression, left bundle-branch block) which precludes analysis of the ST segment shift during PCI
• Patients unable to give informed consent
• Diabetes
• Uncontrolled hypertension (BP\>180/110).
• Anaemia (Hb \<10g/l).

Sponsors & Collaborators

• University Health Network, Toronto: lead
• The Hospital for Sick Children: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Vladimir Dzavik, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir Dzavik, MD

CONTACT

416-340-4800; vlad.dzavik@uhn.on.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 3, 2008

Record last verified: 2008-08