Preclinical research

The Center for Cardiovascular Research and Development (CCRD AHP) was launched in the structures of the American Heart of Poland in 2004.

Medical innovations emerge every day in different parts of the world. In the R&D Centre we cooperate with entities that are determined to launch innovative solutions, especially in the area of cardiology, cardiac surgery, vascular surgery, rehabilitation and telemedicine.

 

We have competence, knowledge and capabilities to support the process of innovation at every stage, from ideas, through pre-clinical and clinical trials, to presentations at international conferences and congresses.

The CCRD AHP is responsible for conducting large-scale, international, randomized clinical trials, coordinating multiple American Heart of Poland clinical centers as well as cooperating hospitals.

Due to the cutting-edge equipment and highly qualified staff including interventional cardiologists, cardiac surgeons, vascular surgeons and pathologists we conduct high-quality translational research aimed at introducing into everyday clinical practice new technologies. In our facility the latest medical discoveries have a chance for safe transfer to the operating room, where they can save patients’ lives.

Facilities and equipment:

a fully equipped hemodynamics room based on GE angiography

an operating room

magnetic resonance imaging (MRI) – MRI Signa EXCITE 1.5T

ultrasound VIVID 6

high definition intravascular ultrasound (IVUS)

intravascular optical coherence tomography (OCT)

systems for vital signs monitoring

devices to enable the preparation of samples for histopathological analysis

tissue and cell culture laboratory

cell separator

soft, hard tissue and implant pathology laboratory

image analysis software angiography (GE OEC 9800) and statistical tools

Broadband Internet connection to enable live broadcasts

conference room

Preclinical Research Laboratory has carried on work and possesses models to evaluate:

intravascular stents (coronary stents, carotid stents, renal stents, peripheral stents, etc.)

surgical and transcatheter heart valves (TAVI, AVR, MVR)

intravascular administration of stem cells.

tests on angioplasty balloons coated with antiproliferative drugs.

angioplasty balloons with local administration of drugs and self-expanding stents.

conducting trainings for physicians in the field of thrombectomy and implantation of self-expanding stents.

Innovation cycle:

1. Innovation

We consult the assumptions of each project, we advise and optimize the planned course of study, with a view to introducing a solution to clinical practice.

2. Formal aspects

We support obtaining research authorizations from relevant institutions (Ethical Committee for Experiments on Animals, Bioethics Committee, Office for Registration of Medicinal Products).

3. Preclinical studies

At the Experimental Laboratory of the R&D Centre, which is also affiliated with Andrzej-Frycz Modrzewski Kraków Univeristy we conduct research in accordance with all requirements and standards applicable in Poland, the European Union and the USA. Location of the Preclinical Research Laboratory at the Institute of Animal Production ensures the availability of a number of animal models and professional care of animals. The Laboratory is adapted to perform surgical procedures requiring general anaesthesia.

We provide:

Imaging diagnostics

Histopathology and other laboratory test

An international network of reference centers

Experienced researchers

4. Clinical trials

After the completion of pre-clinical phase, we provide a unique opportunity to continue the study in the experienced clinical centers of American Heart of Poland and collaborating centers. First-in-Man studies are the first step in obtaining a CE Mark and then introducing a product into the market, followed by a full, multi-center clinical trial.

We provide:

test protocol preparation

training to the research team

People involved in implementation of a study: lead investigator, investigator, clinical trial coordinator, department head, nurse staff, technical staff.

The course of the study is monitored by an independent entity and verified for adverse events.

Market analysis for selected technologies and treatment modalities

a final report summarizing the course and the results of the study

5. Implementation and dissemination of results

R&D Centre staff conducts training of physicians concerning the use of new medical devices and the implementation of new surgical techniques. It is worth pointing out that the results of research conducted in the R&D Centre are widely published in prestigious international journals and presented during conferences and congresses.

If you are interested in cooperation in field of preclinical studies, don’t hesitate to contact us: