Remote Ischaemic Conditioning and Coronary Endothelial Function (RIC-COR)

NCT02666235 | Completed Phase 2

• 3 other identifiers: 11/CARD/03R11/A13610/S0704/52
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Intermittent arm cuff inflation reduces the extent of heart muscle injury at the time of cardiovascular injury. The intervention is known as remote ischaemic conditioning (RIC) however the mechanisms by which RIC acts are incompletely understood. One mechanism that might explain the benefits of RIC is an improvement in coronary artery function which in turn might help improve blood flow to heart muscle. The investigators will perform a randomised controlled study of RIC in a minimum of 60 patients with known or suspected angina and in whom coronary angiography with angioplasty would be considered. Following informed consent before the invasive procedure, the patient will be randomly assigned to the intervention group (cuff inflation protocol) or the control group (cuff placement, no inflation; sham protocol). Following initial coronary angiography, endothelial function will be assessed by intra-coronary infusion of acetylcholine in incremental doses. Coronary diameter will be measured after the procedure using quantitative coronary angiography, by a trained observer blinded to the allocated group. Since a neuro-hormonal response may potentially mediate RIC, a blood test will be performed before and after cuff placement in all patients (active and control groups) to measure circulating molecules known to regulate blood vessel function which may be implicated in a RIC-mediated effect on coronary artery tone. This study may provide clinically relevant insights into the mechanisms of action of RIC in patients with coronary heart disease.

Conditions

Ischemic Preconditioning; Coronary Disease

Outcome Measures

Primary Outcomes (1)

• Coronary artery diameter change

  The net percentage change in mean coronary artery diameter (endothelial function) following intra-coronary administration of study drug (ACh or glyceryl trinitrate) compared to baseline.

  Intra-procedure

Secondary Outcomes (9)

• Circulating molecules reflecting endothelial function and oxidative stress

  Peri-procedure; from baseline up to 2 hours

• Mean percentage change in coronary lumen diameter (delta CAD)

  Intra-procedure - After intracoronary infusion of intra-coronary acetylcholine

• Mean percentage coronary vasoconstriction

  Intra-procedure - After intracoronary infusion of intra-coronary acetylcholine

• Coronary endothelial dysfunction

  Intra-procedure - After intracoronary infusion of intra-coronary acetylcholine

• Mean percentage change in coronary lumen diameter (delta CAD)

  Intra-procedure - After intracoronary injection of glyceryl trinitrate

Study Arms (2)

Remote ischaemic conditioning

ACTIVE COMPARATOR

Intermittent inflation of a forearm blood pressure cuff for 5 minute periods at 200 mmHg separated by a 5 minute rest interval, repeated successively on 4 occasions over a 40 minute period. The intervention will take place on the ward with the patient obscured from the clinical team by a curtain.

Procedure: Remote ischaemic conditioning

Control group

SHAM COMPARATOR

Sham intervention: Arm cuff placement but without inflation during a 40 minute period. A curtain will obscure the patient from the clinical team during this time. Arm cuff placement, no inflation.

Procedure: Arm cuff placement, no inflation;

Interventions

Remote ischaemic conditioning PROCEDURE

Intermittent inflation of an arm blood pressure cuff for 5 minute periods at 200 mmHg separated by a 5 minute rest interval, repeated successively on 4 occasions over a 40 minute period. The intervention will take place on the ward with the patient obscured from the clinical team by a drawn curtain. The clinical team and researchers will be masked to the intervention type.

Also known as: Ischaemic preconditioning, Remote ischemic preconditioning

Remote ischaemic conditioning

Arm cuff placement, no inflation; PROCEDURE

Sham procedure involving arm cuff placement, no inflation: A blood pressure cuff will be placed on the arm for 40 minutes. The cuff will not be inflated. The patient will be in bed behind a curtain on the cardiology ward. The curtain will obscure the patient from the attending cardiology team. The clinical team and researchers will be masked to the intervention type.

Also known as: Sham procedure

Control group

Eligibility Criteria

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

You may qualify if:

• Age 18 or over
• Known or suspected coronary artery disease
• A clinical indication for coronary angiography.

You may not qualify if:

• Myocardial infarction within 2 weeks
• History of coronary artery bypass surgery
• Second or third degree atrioventricular block
• Written informed consent.

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead
• University of Glasgow: collaborator
• Chest, Heart and Stroke Association Scotland: collaborator
• Chief Scientist Office of the Scottish Government: collaborator

Study Sites (1)

Golden Jubilee National Hospital

Glasgow, Dunbartonshire, G814DY, United Kingdom

Location

Related Publications (21)

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MeSH Terms

Conditions

Coronary Disease

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Colin Berry, PhD FRCP

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology and Imaging

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: January 28, 2016
• Study Start: July 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)