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The Effect of Glucocorticoid Therapy on Left Ventricular Remodelling in Acute Myocardial Infarction (RECONSIDER) (RECONSIDER)

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ClinicalTrials.gov Identifier: NCT03371784
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Romanian Governmental Funding (UEFISCDI)
Information provided by (Responsible Party):
Adrian Corneliu Iancu, Iuliu Hatieganu University of Medicine and Pharmacy

Brief Summary:

Introduction: In the setting of acute ST-segment elevation myocardial infarction (STEMI) coronary wedge pressure (CWP) emerges as a new marker for the advanced form of pre-procedural microvascular obstruction (MVO), which is associated with inflammatory interstitial edema. Through its anti-inflammatory effects, glucocorticoid therapy may prove beneficial in patients with high CWP.

Aim: To identify the presence of the advanced form of MVO before primary percutaneous coronary intervention (PPCI) by CWP measurement and to test the benefit of cortisol therapy, in terms of infarct size and left ventricular remodeling, in patients with raised CWP.

Methods: 50 patients with a first STEMI, candidates for PPCI, with proximal coronary occlusion, will undergo CWP measurement followed by percutaneous revascularization. Cardiac MRI will be performed 3-5 days after the procedure. A cutoff for CWP in predicting MVO, interstitial oedema and intramyocardial haemorrhage will be derived.Based on the above mentioned cutoff, 180 patients with continuous elevation of the pressure line will be randomized, by a 1:1 model, either to cortisol therapy or to placebo. Inflammatory parameters will be determined from peripheral blood samples. Patients will undergo cardiac magnetic resonance (CMR) imaging 3 to 5 days after revascularization.

Study endpoints: The primary endpoint will be the extent of MVO, interstitial edema and hemorrhage. Secondary endpoints will include infarct size, myocardial salvage, left ventricular volumes and ejection fraction. The clinical endpoints of all-cause and cardiovascular death, myocardial re-infarction, target vessel revascularization, stent thrombosis and stroke will be recorded at 6 months.


Condition or disease Intervention/treatment Phase
ST-segment Elevation Myocardial Infarction Left Ventricular Remodeling Drug: Hydrocortisone Drug: Placebo Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 model randomization
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Glucocorticoid Therapy on Left Ventricular Remodelling in Acute ST-segment Elevation Myocardial Infarction (RECONSIDER)
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: Hydrocortisone
Patients who meet the inclusion criteria, with a CWP above the derived cutoff, with continuous elevation of the pressure line, who are randomized to i.v hydrocortisone administration.
Drug: Hydrocortisone
I.V. administration
Other Name: no other name

Placebo Comparator: Placebo
Patients who meet the inclusion criteria, with a CWP above the derived cutoff, with continuous elevation of the pressure line, who are randomized to placebo (sodium chloride 0.9%).
Drug: Placebo
I.V. administration
Other Name: sodium chloride 0.9%




Primary Outcome Measures :
  1. The extent of interstitial edema [ Time Frame: 3-5 days ]
    Cardiac magnetic resonance (CMR) assessment (% of left ventricular end-diastolic mass)


Secondary Outcome Measures :
  1. The extent of microvascular obstruction [ Time Frame: 3-5 days ]
    Cardiac magnetic resonance (CMR) assessment (% of left ventricular end-diastolic mass)

  2. The extent of intramyocardial haemorrhage [ Time Frame: 3-5 days ]
    Cardiac magnetic resonance (CMR) assessment (% of left ventricular end-diastolic mass)

  3. Infarct size [ Time Frame: 3-5 days ]
    CMR assessment (% of left ventricular end-diastolic mass)

  4. Myocardial salvage [ Time Frame: 3-5 days ]
    CMR assessment (area at risk minus infarct size divided by area at risk multiplied by100)

  5. Left ventricular ejection fraction [ Time Frame: 3-5 days and 6 months after the procedure ]
    CMR and echocardiographic assessment (%)

  6. Left ventricular end-systolic volume [ Time Frame: 3-5 days and 6 months after the procedure ]
    CMR and echocardiographic assessment (ml)

  7. Left ventricular end-diastolic volume [ Time Frame: 3-5 days and 6 months after the procedure ]
    CMR and echocardiographic assessment (ml)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age: 18-85 years
  • first episode of ST-segment elevation myocardial infarction
  • candidates for primary PCI (typical cardiac chest pain, within 12h of symptom onset, with ST-segment elevation of more than 1 mm in at least two contiguous leads)
  • left anterior descending artery culprit lesion

Exclusion Criteria:

  • cardiogenic shock
  • previous PCI and coronary artery bypass surgery (CABG)
  • left bundle branch block
  • active bleeding
  • administration of thrombolytic agents for the current episode
  • recent stroke (during last month)
  • indication for oral anticoagulant therapy
  • severe or untreated infection
  • the impossibility of CWP measurement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371784


Contacts
Contact: Adrian Corneliu Iancu, M.D, Ph.D +40744751027 adrian_iancu@hotmail.com
Contact: Ioana Mihaela Dregoesc, M.D ioanadregoesc@yahoo.com

Locations
Romania
"Niculae Stancioiu" Heart Institute Recruiting
Cluj-Napoca, Cluj, Romania, 400001
Contact: Adrian C Iancu, MD, PhD    +40744751027    adrian_iancu@hotmail.com   
Sponsors and Collaborators
Iuliu Hatieganu University of Medicine and Pharmacy
Romanian Governmental Funding (UEFISCDI)
Investigators
Principal Investigator: Adrian Corneliu Iancu, M.D, Ph.D "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca

Publications:

Responsible Party: Adrian Corneliu Iancu, Professor of Cardiology, Iuliu Hatieganu University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT03371784     History of Changes
Other Study ID Numbers: PN-III-P4-ID-PCE-2016-0393
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Adrian Corneliu Iancu, Iuliu Hatieganu University of Medicine and Pharmacy:
Acute myocardial infarction
Left ventricular remodeling
Coronary wedge pressure
Glucocorticoid therapy

Additional relevant MeSH terms:
Glucocorticoids
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ventricular Remodeling
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs