Clinical trial NCT02313441: Cardio- and Renoprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention
Official title: Cardio- and Reno-protective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention. A Prospective, Non-randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: remote ischemic preconditioning
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Incidence of PCI- related myocardial infarction (MI 4a) at 24 hours after PCI.
timeFrame: 24 hours
Secondary outcomes:
measure: incidence of contrast induced nephropathy (CIN) at 72 hours after contrast exposure
timeFrame: 72 hours
Other outcomes:
measure: Chest pain severity during PCI
timeFrame: 1 hours
measure: level of C-reactive protein (CRP)24 hr post PCI
timeFrame: 24h post procedure
measure: major adverse events (MAE) at 3 month follow up
timeFrame: 90 days Follow-up
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
Study officials:
affiliation: Assiut University
name: Ayman KM Hassan, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.