Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01956708
Other study ID # RIPC-13-5507-BO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date April 20, 2020

Study information

Verified date October 2021
Source University Hospital, Essen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion provides peri-operative myocardial protection, is safe and improves prognosis in patients undergoing elective CABG surgery. The signal transfer from limb to heart is unknown. Thus, the aim of this study is to identify the pathways which transfer the cardioprotective signal from the ischemic/reperfused extremity to the heart in humans undergoing surgical coronary revascularization.


Description:

The investigators will obtain arterial blood samples before skin incision and 1-72 h after the remote ischemic preconditioning protocol and analyze them biochemically. The investigators focus on those ligands that have been previously implicated in conditioning protocols at any organ. In addition, the investigators will use a bioassay system, consisting of a Langendorff-perfused isolated heart with coronary occlusion/reperfusion and infarct size by TTC staining as endpoint, and then expose this bioassay system to arterial plasma obtained after the remote ischemic preconditioning stimulus or placebo. This approach will allow us to further characterize any potential transfer signal candidate with a pharmacological antagonist approach. The investigators will also obtain human atrial appendages after the remote ischemic preconditioning protocol or placebo and before patients were connected to the extracorporeal circulation. Contractile function of isolated trabeculae and vasomotor function of isolated arterial vessels will be analyzed in a bioassay system.


Recruitment information / eligibility

Status Completed
Enrollment 392
Est. completion date April 20, 2020
Est. primary completion date April 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Consecutive patients > 18 years after written informed consent - elective, isolated CABG surgery with and without valvuloplastic surgery - two-stage cannulation, cardiopulmonary bypass - antegrade Bretschneider cardioplegia - mild hypothermia (32°C) - preoperative standard medication (statins, betablocker, aspirin) - standard anesthesia (see above) - intraoperative standard protocol (full heparinization with ACT, aprotinin, protamin) - postoperative standard protocol (500 mg aspirin after 2 h, low-dose heparin after 4 h) Exclusion Criteria: preoperative - prior percutaneous coronary intervention (PCI) within 6 weeks - any preoperative troponin T elevation - renal insufficiency (creatinine >200 µmol/l) - reoperation - emergency surgery - acute coronary syndrome (unstable angina, STEMI, NSTEMI) within 4 weeks - dual anti-platelet therapy (clopidogrel+aspirin) intraoperative - harvesting of a. radialis - coronary thrombendarterectomy - complications (bypass-low flow/ -occlusion) - antithrombotic therapy (intraoperative clopidogrel + aspirin) - retrograde cardioplegia

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
RIPC
3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion

Locations

Country Name City State
Germany Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen Essen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myocardial protection Cumulative postoperative troponin T release 72 h, postoperatively
Secondary All-cause mortality follow up done by studynurses 30 days and 1 year after CABG surgery and after complete follow-up
Secondary MACCE Major adverse cardiac and cerebrovascular events 30 days and 1 year after CABG surgery after complete follow-up
Secondary renal function Creatinine and eGFR 72 h, postoperatively
Secondary Cardioprotective factors released into circulating blood Analysis of blood plasma before skin incision versus 1-72 h after RIPC
Secondary Myocardial function in vitro left ventricular pressure (lvp) and maximum left ventricular pressure (lvdp) in an isolated perfused rodent heart after blood plasma infusion after RIPC
See also
  Status Clinical Trial Phase
Completed NCT01928745 - Experimental Determination of Atot en Ka in the Critically Ill N/A
Active, not recruiting NCT00966654 - Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass (CABG) Surgery Phase 2
Completed NCT00524901 - Study of the Use of a Single Dose of Erythropoietin to Treat Acute Myocardial Ischemia Phase 2
Completed NCT01282671 - Effects of Deep Breathing Exercises Two Months After Cardiac Surgery Phase 2
Completed NCT03050489 - Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG
Recruiting NCT06124937 - Empagliflozin to Prevent Post-Operative Atrial Fibrillation Phase 3
Completed NCT00269243 - Management With Accupril Post Bypass Graft Phase 4
Recruiting NCT03139929 - Measurement of MSFP and Stressed Volume With CardioQ+®
Active, not recruiting NCT03424941 - The TransCatheter Valve and Vessels Trial N/A
Completed NCT06317363 - Effects of Acapella VS CHEST Physiotherapy in Post-Operative CABG Patients N/A
Completed NCT05023083 - Cross Cultural Adaptation of Functional Status Questionnaire in Urdu Language in CABG Patients
Completed NCT03800264 - Bisoprolol Versus Corticosteroid and Bisoprolol Combination for Prophylaxis Against Atrial Fibrillation After on Pump Coronary Artery Bypass Surgery Phase 4
Completed NCT05285865 - Scapular Mobilization on Inspiratory Capacity of Post-CABG Patients N/A
Not yet recruiting NCT06173609 - Long LIMA Patch on Left Anterior Descending Coronary Artery in CABG
Not yet recruiting NCT06238011 - Dexmedetomidine vs Control on Attenuation Hemodynamic Response to Noxious Stimuli in CABG Surgical Patients N/A
Active, not recruiting NCT06127147 - High-intensity Inspiratory Muscle Training as a Pre-cardiac Rehabilitation in Heart Disease N/A
Recruiting NCT06029556 - Effects of Early Mobility Protocols in Cardiac ICU N/A
Enrolling by invitation NCT01205620 - IRB-HSR# 15084 A Prospective, Unblinded, Controlled Study to Evaluate the Effect of the ITPR in Patients Undergoing OPCAB Surgery Phase 2