Coronary Artery Disease
Conditions
Keywords
remote ischemic preconditioning
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).
Interventions
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
Sponsors
Assiut University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PCI- related myocardial infarction (MI 4a) at 24 hours after PCI. | 24 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| incidence of contrast induced nephropathy (CIN) at 72 hours after contrast exposure | 72 hours | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chest pain severity during PCI | 1 hours | Chest pain severity during PCI was graded on a scale of 0 for no pain to 10 for the most severe discomfort ever experienced |
| level of C-reactive protein (CRP)24 hr post PCI | 24h post procedure | C-reactive protein level was measured 24 hr. post PCI to assess the inflammatory response . |
| major adverse events (MAE) at 3 month follow up | 90 days 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. |
Countries
Egypt
Outcome results
None listed