IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction (PRESERVATION 1)
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|ClinicalTrials.gov Identifier: NCT01226563|
Recruitment Status : Completed
First Posted : October 22, 2010
Last Update Posted : December 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction Congestive Heart Failure ST-Elevation Myocardial Infarction||Device: Sodium Alginate and Calcium Gluconate Device: Saline Solution||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||306 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||December 2015|
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.
- 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
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): NCT01226563
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|Study Director:||Reinilde Heyrman, M.D.||Bellerophon BCM LLC|