Back to resultsCardio- and Renoprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Remote Ischemic Pre-Conditioning
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring remote ischemic preconditioning
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.
Sites / Locations
- Assiut University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
RIPC (Remote Ischemic Pre-Conditioning)
Control
Arm Description
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
Control participants did not experience this procedure of transient upper-limb ischemia.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02313441
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
remote ischemic preconditioning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RIPC (Remote Ischemic Pre-Conditioning)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control participants did not experience this procedure of transient upper-limb ischemia.
Intervention Type
Other
Intervention Name(s)
Remote Ischemic Pre-Conditioning
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of PCI- related myocardial infarction (MI 4a) at 24 hours after PCI.
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
incidence of contrast induced nephropathy (CIN) at 72 hours after contrast exposure
Description
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.
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
Chest pain severity during PCI
Description
Chest pain severity during PCI was graded on a scale of 0 for no pain to 10 for the most severe discomfort ever experienced
Time Frame
1 hours
Title
level of C-reactive protein (CRP)24 hr post PCI
Description
C-reactive protein level was measured 24 hr. post PCI to assess the inflammatory response .
Time Frame
24h post procedure
Title
major adverse events (MAE) at 3 month follow up
Description
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.
Time Frame
90 days Follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman KM Hassan, MD. PhD.
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University Hospitals
City
Assiut
ZIP/Postal Code
71526
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
17846333
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.
Results Reference
background
PubMed Identifier
19188504
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.
Results Reference
background
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Cardio- and Renoprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention
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