Cardio- and Renoprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention

Coronary Artery Disease Clinical Trial

Official title:

Cardio- and Reno-protective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention. A Prospective, Non-randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313441
• Other study ID #: RIPC1
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Other:
• Remote Ischemic Pre-Conditioning
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

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chest pain severity during PCI	Chest pain severity during PCI was graded on a scale of 0 for no pain to 10 for the most severe discomfort ever experienced	1 hours
Other	level of C-reactive protein (CRP)24 hr post PCI	C-reactive protein level was measured 24 hr. post PCI to assess the inflammatory response .	24h post procedure
Other	major adverse events (MAE) at 3 month follow up	Death was defined as "all-cause" death at follow-up. Acute coronary syndrome (ACS) was defined using standard diagnostic criteria. Heart failure (HF) during follow-up, was defined as either the presence of rales in more than one third of the lung fields that did not clear with coughing or evidence of pulmonary oedema on chest radiograph. Hemodialysis as a complication of acute deterioration of renal function post PCI was also calculated. Only the most serious event of MAE was used to calculate the cumulative MAE per patient according to the following sequence: death>ACS > HF> Hemodialysis.	90 days Follow-up
Primary	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	incidence of contrast induced nephropathy (CIN) at 72 hours after contrast exposure	CIN was defined as an increase in the serum creatinine level of more than 0.5 mg/dl or more than 25 % from baseline within 3 days after procedure without any other identifiable cause of acute kidney injury.	72 hours