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
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 model randomization|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
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%).
Other Name: sodium chloride 0.9%
- The extent of interstitial edema [ Time Frame: 3-5 days ]Cardiac magnetic resonance (CMR) assessment (% of left ventricular end-diastolic mass)
- The extent of microvascular obstruction [ Time Frame: 3-5 days ]Cardiac magnetic resonance (CMR) assessment (% of left ventricular end-diastolic mass)
- The extent of intramyocardial haemorrhage [ Time Frame: 3-5 days ]Cardiac magnetic resonance (CMR) assessment (% of left ventricular end-diastolic mass)
- Infarct size [ Time Frame: 3-5 days ]CMR assessment (% of left ventricular end-diastolic mass)
- Myocardial salvage [ Time Frame: 3-5 days ]CMR assessment (area at risk minus infarct size divided by area at risk multiplied by100)
- Left ventricular ejection fraction [ Time Frame: 3-5 days and 6 months after the procedure ]CMR and echocardiographic assessment (%)
- Left ventricular end-systolic volume [ Time Frame: 3-5 days and 6 months after the procedure ]CMR and echocardiographic assessment (ml)
- Left ventricular end-diastolic volume [ Time Frame: 3-5 days and 6 months after the procedure ]CMR and echocardiographic assessment (ml)
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
|Contact: Adrian Corneliu Iancu, M.D, Ph.Demail@example.com|
|Contact: Ioana Mihaela Dregoesc, M.Dfirstname.lastname@example.org|
|"Niculae Stancioiu" Heart Institute||Recruiting|
|Cluj-Napoca, Cluj, Romania, 400001|
|Contact: Adrian C Iancu, MD, PhD +40744751027 email@example.com|
|Principal Investigator:||Adrian Corneliu Iancu, M.D, Ph.D||"Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca|