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Completed

NCT Number: NCT02313441

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

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).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospitals

Asyut, 71526, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote Ischemic Pre-Conditioning

Other

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 outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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 outcomes

  1. Chest pain severity during PCI

    Time frame: 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

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

    Time frame: 24h post procedure

    C-reactive protein level was measured 24 hr. post PCI to assess the inflammatory response .

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2014
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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