CardiAMP CMI Randomized Controlled Pivotal Trial in Patients With Chronic Myocardial Ischemia and Refractory Angina (CardiAMP CMI)
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|ClinicalTrials.gov Identifier: NCT03455725|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : March 9, 2018
Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment
Subjects treated with aBMC using the CardiAMP cell therapy system
Sham Control Group:
Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)
|Condition or disease||Intervention/treatment||Phase|
|Refractory Angina Chronic Myocardial Ischemia||Device: CardiAMP Cell Therapy System Other: Sham Treatment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||343 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, multi-center, 2:1 randomized (Treatment vs Sham Control), blinded trial comparing 2 paralel groups of patients with CMI treated with CardiAMP cell therapy system vs sham treatment.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Quadruple-blinded, placebo-controlled study. Patients, investigators, the CRO, core labs and the sponsor will be blinded for individual treatment adjudication.|
|Official Title:||Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial)|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2026|
Active Comparator: CardiAMP cell therapy system
Up to 10 subjects with refractory chronic myocardial ischemia CCS class III-IV will be treated in an unblinded, uncontrolled roll-in phase.
In the subsequent randomized phase:
Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 222 Subjects will be randomized to treatment with the CardiAMP cell therapy system.
Device: CardiAMP Cell Therapy System
The CardiAMP Cell Therapy system consists of the CardiAMP Potency Assay, the Helix/Morph intramyocardial delivery catheter system, and the CardiAMP Cell Separator. The system allows the investigator to identify patients with a high chance to respond to im autologous stem cell therapy (using the CardiAMP Cell Potency Assay), to isolate the stem cells from a bone marrow harvest at the point of care (using the CardiAMP CS system), and to percutaneously inject the autologous cells into the myocardium using the Helix/Morph delivery catheters.
Sham Comparator: Sham procedure control
Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 111 subjects will be treated with a Sham Treatment (no introduction of trans endocardial delivery catheter and no administration of autologous cells)
Other: Sham Treatment
Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed
- Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol [ Time Frame: Baseline and 12 months visit ]A superiority analysis with regards to change from Baseline in Total Exercise Time at the 12 months follow-up visit (using a Modified Bruce Protocol).
- Safety: overall survival at 12 months follow-up [ Time Frame: at 12 months follow-up ]A non-inferiority analysis of overall survival at 12-months will be made comparing the Treatment group to the Sham Control group using a non-inferiority margin of 10%.
- Safety: Total Major adverse cardiac events (MACE) at 12 months follow-up [ Time Frame: from randomisation to 12 months follow-up ]A non-inferiority analysis with regard to Total Major Adverse Cardiac Events (MACE: defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke) at 12 month follow-up, as adjudicated by an independent clinical endpoint classification (CEC) committee with 10% margin.
- Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up [ Time Frame: Baseline and at 6 months follow-up ]Superiority analysis with regards to change from baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at 6 Month Follow-up Visit. Baseline (BL) is the average of (at least) two total exercise times measured during the screening period.
- Efficacy: Change of angina frequency (per week) at 12 months follow-up [ Time Frame: Baseline and at 12 months follow-up ]
Superiority analysis with regards to change in angina frequency (episodes per week) at 12 month follow-up Visit versus baseline angina frequency (per week).
Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 12-month follow-up visits.
- Efficacy: Change of Angina Frequency (per week) at 6 months follow-up [ Time Frame: Baseline and at 6 months follow-up ]
Superiority analysis with regards to change in angina frequency at 6 month follow-up visit versus baseline (expressed as angina frequency per week).
Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline and in the 4 weeks before the 6-month follow-up visits.
- Safety: Total Major adverse cardiac events (MACE) at 24 months follow-up [ Time Frame: From randomisation to 24 month follow-up ]Superiority analysis with regards to incidence of MACE from Randomization until the end of the 24 month follow-up period
- Efficacy: Percentage of patients with at least 1 Serious Adverse Event (SAE) [ Time Frame: From randomization to 24 Months follow-up ]Superiority analysis with regards to percentage of participants with at least one SAE. From randomization until the end of the 24 month follow-up period.
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): NCT03455725
|Contact: Peter Altman, PhD||(650) 226 email@example.com|
|Contact: Eric Duckers, MD PhD FESC||(650) 226 firstname.lastname@example.org|