IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction (PRESERVATION 1)
|Acute Myocardial Infarction Congestive Heart Failure ST-Elevation Myocardial Infarction||Device: Sodium Alginate and Calcium Gluconate Device: Saline Solution||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
|Official Title:||A Placebo Controlled , Multicenter, Randomized, Double Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction - Preservation I Trial|
- Left Ventricular End Diastolic Volume Index [ Time Frame: Baseline, 6 Months ]Anatomic measurement of left ventricular end diastolic volume index (LVEDVI) assessed through echocardiogram.
- Kansas City Cardiomyopathy Questionaire [ Time Frame: Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits ]Patient reported outcomes (PROs) using The Kansas City Cardiomyopathy Questionaire (KCCQ) score - a validated disease-specific self-administered 23-item questionnaire that will be used to quantify symptoms, function, and quality of life of subjects.
- Six minute walk test [ Time Frame: Baseline (prior to discharge STEMI), 1, 3, 6 and 12 month follow-up visits ]The six minute walk test (6MWT) is used for measuring the response to medical interventions in subjects with moderate to severe heart disease, functional status of subjects, as well as a predictor of morbidity and mortality
- New York Heart Association (NYHA) functional classification (Physician reported) [ Time Frame: Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits ]New York Heart Association (NYHA) classification assessed by physician will be categorized by Class (Class I - IV)
- Cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations [ Time Frame: 5 Years ]Time to cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations adjudicated by a Clinical Events Committee
- Re-hospitalization due to any cardiovascular event [ Time Frame: 5 Years ]Time to re-hospitalization due to any cardiovascular event
- NT-pro-brain natriuretic peptide (NT-proBNP) levels [ Time Frame: Baseline, discharge, 1, 3, and 6 month follow-up visits. ]NT-pro-brain natriuretic peptide (NT-proBNP) levels
- Short Form 12 (SF-12) Questionnaire [ Time Frame: Baseline (prior to the index STEMI), 1, 3, 6 and 12 month follow-up visits ]The SF-12 is a validated general quality of life self-administered instrument that has been used in various disease states.
- Measurement of alginate in plasma and urine [ Time Frame: Baseline, 5, 30 min, 1, 3, 8, 24, 48 hrs, 1, 3 month ]
At selected sites, relatively intensive sampling: blood will be drawn just prior to deployment (0 hour), 5 and 30 minutes and 1, 3, 8, 24, 48 hrs post deployment or until discharge, whichever occurs first, and at 1 and 3 month follow-up visit.
At selected sites, urine collection for measurements of alginate, 4 urine samples, will be collected at baseline (within 30 min prior to deployment), 0-8 hrs (from the time immediately following the device deployment through 8 hrs post deployment), 8 through 24 hours through post deployment, 24 through 48 hrs or discharge (whichever comes first). In addition, a urine sample will be taken at 1 and 3 month follow-up visits.
Remaining sites: sparse sampling blood will be drawn at 1, 8 and 24 hours, 1 month and post-deployment.
- Healthcare utilization [ Time Frame: 6 and 12 month follow-up visits. ]The healthcare utilization and questionnaire consists of subject responses to questions regarding mobility, self-care, usual activities, pain, discomfort, anxiety and depression.
- Anatomic endpoints [ Time Frame: 4 to 6 hours following deployment, 1, 3 and 12 month follow-up visits ]Anatomic endpoints: ejection fraction, end systolic volume index, mitral regurgitation, diastolic function, sphericity index, wall thickness, wall motion score and left ventricular (LV) mass index derived from the echocardiogram.
- Primary Safety Evaluation [ Time Frame: 1 Year ]
The following safety endpoints will be adjudicated by a Clinical Events Classification Committee:
- Recurrent myocardial infarction (MI) or target vessel revascularization or stent thrombosis
- Significant arrhythmia requiring therapy
- Myocardial rupture
- Long-term Safety Evaluation [ Time Frame: 1 year to 5 years after device deployment ]
Need for devices for the management of congestive heart failure (CHF)
- automated implantable cardiac defibrillator (AICD)
- cardiac resynchronization therapy
- left ventricular assist device (LVAD)
- Heart transplant
- Continuous Electrocardiogram Cardiac Safety Endpoints [ Time Frame: Baseline, prior to discharge, 1, 3 and 6 month follow-up visits ]
- New ischemia by ST segment deviation
- QT/QTcF (Fridericia's heart rate correction) before and 18 hours after procedure
- Severe bradycardia or tachycardia, including sustained ventricular or supraventricular tachycardia, total beats in episodes of tachycardia, total pauses and newly paced beats.
- Clinical Chemistry, Hematology, and Urinalysis panel [ Time Frame: Clinical Chemistry, Hematology: Baseline, 8 hours (± 2 hours) post-deployment, 1, 3, and 6 month follow-up visits. Urinalysis : Baseline and discharge ]
Chemistry panel - levels of albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, calcium, serum chloride, bicarbonate, direct bilirubin, creatinine, γ-GT, glucose, lactate dehydrogenase, potassium, sodium, and total bilirubin.
Hematology panel - hemoglobin, hematocrit, mean corpuscular volume (MCV), red blood cell count (RBC), white blood cell (WBC) levels (with 5 part differential), and platelet count.
Urinalysis - pH, specific gravity, RBC, WBC, glucose, protein in the urine, and a Human chorionic gonadotropin (HCG) pregnancy test
- Performance Goal and Study Success [ Time Frame: Baseline to 6 months ]5 mL/m2 change or greater in LVEDVI in IK-5001 group vs. placebo
|Study Start Date:||April 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
IK-5001 is a aqueous mixture of sodium alginate and calcium gluconate. A 4 mL (+/- 0.2 mL)slow bolus, intracoronary injection of IK-5001 will be administered over 30 to 60 seconds
Device: Sodium Alginate and Calcium Gluconate
4 mL (+/- 0.2 mL)administered through intracoronary slow bolus injection over 15 to 30 seconds at least 2 days after PCI but within 5 days of onset of symptoms.
Placebo Comparator: Saline Solution
A 4 mL (+/- 0.2 mL)slow bolus intracoronary injection of saline solution will be administered over 30 to 60 seconds
Device: Saline Solution
4 mL (+/- 0.2 mL)slow bolus, intracoronary injection of saline solution will be administered over 15 to 30 seconds at least 2 days after percutaneous coronary intervention (PCI) but within 5 days of onset of symptoms.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226563
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|Study Director:||Reinilde Heyrman, M.D.||Bellerophon BCM LLC|