- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01817114
Chronic Remote Ischemic Conditioning to Modify Post-MI Remodeling (CRIC-RCT)
Chronic Remote Ischemic Conditioning Following Primary Percutaneous Intervention for ST-Elevated Myocardial Infarction
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- Rekruttering
- St. Michael's Hospital
-
Kontakt:
- Niel Fam, RCPSC
- Telefonnummer: 416-864-5466
- E-mail: famn@smh.ca
-
Toronto, Ontario, Canada, M4N 3M5
- Rekruttering
- Sunnybrook Health Sciences Centre
-
Kontakt:
- Harindra Wijeysundera, MD, PhD
- Telefonnummer: 416-480-4527
- E-mail: harindra.wijeysundera@sunnybrook.ca
-
Toronto, Ontario, Canada, M5G 2C4
- Rekruttering
- University Health Network, Toronto General Hospital
-
Ledende efterforsker:
- Chris Overgaard, RCPSC
-
Underforsker:
- Vladimir Dzavik, FRCPC, MD
-
Underforsker:
- Andrew Crean, MSc, FRCR
-
Underforsker:
- Michael Farkouh, MD, MSc
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
(i) Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes; (ii) Antegrade TIMI 0 or 1 prior to PCI; (iii) Age ≥18 years; (iv) Informed consent from patient or next of kin.
Exclusion Criteria:
(i) Known history of diabetes; (ii) Coronary anatomy warranting emergent coronary artery bypass graft surgery; (iii) Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation); (iv) Need for hemodialysis; (v) Malignancy, HIV, or central nervous system disorder; (vi) Cardiopulmonary resuscitation >15 min and compromised level of consciousness; (vii) Cardiogenic shock; (viii) Current participation in any research study involving investigational drugs or devices; (ix) Inability to safely undergo cMRI
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Chronic Remote Ischemic Conditioning
Remote ischemic conditioning will be induced using an AutoRIC device (occluding arm bloodflow exactly like manual bloodpressure cuff).
With the participant in a supine or seated upright position, the AutoRIC device will be placed on the right arm and will inflate to a pressure of 200mmHg for 5 minutes (ischemia).
The device will then auto-deflate (reperfusion), completing one cycle of ischemia-reperfusion.
A total of 4 inflation and deflation cycles will occur.
This will be initiated at first medical contact just prior to the performance of primary PCI in eligible subjects (RIPerC), and then repeated daily for 28 days following MI.
|
|
Sham-komparator: SHAM Remote Ischemic Conditioning
Sham conditioning will involve the AutoRIC device being placed on the right arm and will inflate to a pressure of 10mmHg for 5 minutes (ie.
no limb ischemia will occur).
The device will then auto-deflate, completing one cycle.
A total of 4 inflation and deflation cycles will occur.
This will be initiated at first medical contact just prior to the performance of primary PCI in eligible subjects (RIPerC), and then repeated daily for 28 days following MI.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in LVEDV from baseline
Tidsramme: 28 days post-surgery
|
The primary outcome of this study will be the change from baseline in left ventricular end diastolic volume (LVEDV) at 28 days post-PCI by cardiac MRI.
|
28 days post-surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
change in LVESV from baseline
Tidsramme: 28 days post-surgery
|
change from baseline in left ventricular end systolic volume (LVESV), ejection fraction (LVEF) and mass at 28 days post-PCI by cardiac MRI
|
28 days post-surgery
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Andrew Redington, FRCPC, The Hospital for Sick Children
- Ledende efterforsker: Christopher Overgaard, RCPSC, University Health Network, Toronto General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1000038045
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