Clinical trial NCT00119834: Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
Official title: Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Heart Failure, Congestive
Keywords: Heart Failure
Intermacs
Pedimacs
Mechanical Circulatory Support
Ventricular Assist Device
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2005-07-14
Enrollment: 23472
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end-stage heart failure that receive a legally utilized mechanical circulatory support device.

Brief summary: The Intermacs registry is a national quality improvement system designed to advance the understanding and application of mechanical circulatory support in order to improve the duration and quality of life in patients with advanced heart failure.

Detailed description: Background:

Over the last several decades, MCSDs have been developed to augment or supplant failing myocardial performance. This therapy has been used successfully as a bridge to heart transplantation, a bridge to recovery, and as permanent implantation or "destination therapy" for intractable heart failure. Although heart transplantation offers life-saving therapy for selected patients, its use is limited by a supply of donor organs that currently meets less than one-tenth the need. As a consequence, the number of MCSD implantations has increased in recent years.

Despite favorable survival and quality of life outcomes, MCSDs do have severe and sometimes life-threatening complications, including infection, thrombosis, and device failure. The development of new procedures and devices to reduce these complications will be expedited by the work of the registry involving the systematic, independent analysis of MCSD implantation procedures and outcomes. The National Heart, Lung, and Blood Institute (NHLBI) will collaborate with the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) in monitoring the work of the registry to permit the development of standard reporting of patient characteristics, indications, implantation procedures, and adverse events.

Intermacs Design Narrative:

The goals of the registry include the following:

1. Develop standard methods to collect data used to characterize heart failure patients receiving MCSDs, and develop methods of collecting demographic data of device use patient outcomes
2. Collect, process, and store patients' clinical data
3. Analyze collected data
4. Provide these resources to researchers outside the registry
5. Publish and disseminate results

Intermacs has included pediatric patients since the inception of the registry in 2006 with an increased effort in September 2012 to include pediatric subjects. This focus is called Pedimacs. Pedimacs utilizes the Intermacs protocol. Due to collection of pediatric-only data elements, a separate Users' Guide has been developed for Pedimacs.

Intermacs now serves as the national quality improvement system to assess the characteristics, treatments and outcomes of patients receiving legally utilized mechanical circulatory support devices. The protocol has undergone several changes since its inception in 2006. The Current protocol (Protocol 5.0) reflects the latest changes and the necessity for a waiver of informed consent and authorization for participants.

In January 2013 the Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support (Medamacs) was established to capture data on patients with advanced heart failure who were not receiving mechanical circulatory support devices. The aims of Medamacs are to:

1. Identify prospectively a population of ambulatory patients on optimal medical therapy for whom chronic heart failure limits both function and survival to a range where elective implantation of left ventricular assist devices should offer meaningful benefit.
2. Design an integrated endpoint of survival and objective functional assessment that provides more discrimination between chronic ambulatory heart failure and current device outcomes than survival alone.
3. Evaluate patient perceptions about their cardiac condition, ventricular assist device technology, preferences for their care, and thresholds for considering device implant.

Enrollment in Medamacs has closed.

The clinicaltrials.gov identification number for Medamacs is NCT01932294.

Eligibility criteria: Inclusion Criteria:

* Legally utilized MCSD implanted on or after March 1, 2006; every consented patient who receives an eligible MCSD at a participating center will be enrolled, regardless of reason (i.e., bridge-to-recovery, bridge-to-alternative bridge, bridge-to-clinical improvement for transplant eligibility, bridge-to-transplant, destination therapy). Beginning June 1, 2014, and with lnstitutional Review Board approval, participating sites may enroll patients under a waiver of informed consent and authorization.
* Eligible devices include all of the following: 1) approved devices for any indications; 2) Intermacs-linked trial of investigational device or approved device for investigational indications, for which data will be entered via the Intermacs framework; 3) external trial of investigational device or approved device for investigational indications, for which data will be collected by an external group; 4) compassionate use of investigational devices or approved devices outside of approved indications or clinical trials

Exclusion Criteria:

* Currently incarcerated

Primary outcomes:
measure: Collect and analyze clinical and laboratory data from patients who are receiving mechanical circulatory support devices (MCSD) for end-stage heart failure.
timeFrame: Collected as part of the registry
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: James K. Kirklin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brisco MA, Kimmel SE, Coca SG, Putt ME, Jessup M, Tang WW, Parikh CR, Testani JM. Prevalence and prognostic importance of changes in renal function after mechanical circulatory support. Circ Heart Fail. 2014 Jan;7(1):68-75. doi: 10.1161/CIRCHEARTFAILURE.113.000507. Epub 2013 Nov 8.