NCT02313441

Brief Summary

Myocyte necrosis occurs frequently in elective percutanious percutaneous coronary intervention (PCI) and is associated with subsequent cardiovascular events. This study assessed the cardio- and reno-protective effect of remote ischemic preconditioning (RIPC) in patients undergoing elective PCI. 200 patients were randomized into 2 groups: 100 patients received RIPC (created by three 5-minute inflations of a blood pressure cuff to 200 mm Hg around the upper arm, separated by 5-minute intervals of reperfusion) \< 2 hours before the PCI procedure, and the control group (n = 100).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

December 7, 2014

Last Update Submit

September 16, 2019

Conditions

Coronary Artery Disease

Keywords

remote ischemic preconditioning

Outcome Measures

Primary Outcomes (1)

  • Incidence of PCI- related myocardial infarction (MI 4a) at 24 hours after PCI.

    PCI-related myocardial infarction (MI 4a) was defined as cardiac Troponin I (cTnI) elevation \>0.20ng/mL (5 times the upper reference limit) 24 hr. post PCI.

    24 hours

Secondary Outcomes (1)

  • incidence of contrast induced nephropathy (CIN) at 72 hours after contrast exposure

    72 hours

Other Outcomes (3)

  • Chest pain severity during PCI

    1 hours

  • level of C-reactive protein (CRP)24 hr post PCI

    24h post procedure

  • major adverse events (MAE) at 3 month follow up

    90 days Follow-up

Study Arms (2)

RIPC (Remote Ischemic Pre-Conditioning)

ACTIVE COMPARATOR

Patients used RIPC had a blood pressure cuff placed around their upper arm at \< 2 hours before the PCI procedure. The blood pressure cuff was inflated to for 5 minutes, followed by 5 minutes of deflation. This procedure was repeated 3 times

Other: Remote Ischemic Pre-Conditioning

Control

PLACEBO COMPARATOR

Control participants did not experience this procedure of transient upper-limb ischemia.

Other: Remote Ischemic Pre-Conditioning

Interventions

Remote Ischemic Pre-ConditioningOTHER

The blood pressure cuff was inflated to a pressure of 200 mm Hg for 5 minutes, followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated 3 times by the resident doctors in the pre-cath room

ControlRIPC (Remote Ischemic Pre-Conditioning)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18 and 85 years of age,
  • scheduled to undergo an elective PCI and
  • able to give an informed consent were eligible for enrollment in the study.
  • Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI.

You may not qualify if:

  • (1) emergency PCI, (2) baseline troponin value ≥ 0.04 ng/mL, (3) nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively), (4) those who could not give informed consent, and (5) patients with severe renal impairment or on regular dialysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, 71526, Egypt

Location

Related Publications (2)

  • Ali ZA, Callaghan CJ, Lim E, Ali AA, Nouraei SA, Akthar AM, Boyle JR, Varty K, Kharbanda RK, Dutka DP, Gaunt ME. Remote ischemic preconditioning reduces myocardial and renal injury after elective abdominal aortic aneurysm repair: a randomized controlled trial. Circulation. 2007 Sep 11;116(11 Suppl):I98-105. doi: 10.1161/circulationaha.106.679167.

    PMID: 17846333BACKGROUND

  • Hoole SP, Heck PM, Sharples L, Khan SN, Duehmke R, Densem CG, Clarke SC, Shapiro LM, Schofield PM, O'Sullivan M, Dutka DP. Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study: a prospective, randomized control trial. Circulation. 2009 Feb 17;119(6):820-7. doi: 10.1161/CIRCULATIONAHA.108.809723. Epub 2009 Feb 2.

    PMID: 19188504BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ayman KM Hassan, MD. PhD.

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 7, 2014

First Posted

December 10, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

December 1, 2014

Last Updated

September 18, 2019

Record last verified: 2019-09

Locations

EG(1)