NCT00388245

Brief Summary

REHEAT 2 study is designed as a prospective, randomised trial comparing two strategies of myocardial revascularisation (PCI vs CABG) in patients with ischemic cardiomyopathy and low left ventricular ejection fraction.Patients will undergo in random way PCI or CABG procedure. The aim the study is to assess the improvement of left ventricle systolic function and comparing recent (30 days) and late (12 months) results of surgical (CABG) and percutaneous (PCI) revascularization.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 16, 2006

Status Verified

October 1, 2006

First QC Date

October 13, 2006

Last Update Submit

October 13, 2006

Conditions

Left Ventricular Ejection FractionMyocardial RevascularizationIschemic Heart Disease

Keywords

PCICABGEjection FractionMyocardial Revascularization

Outcome Measures

Primary Outcomes (1)

  • LV ejection fraction after 1 year since the index procedure

Secondary Outcomes (4)

  • in-hospital and 30 day major adverse events (MAE) and major adverse cardiovascular events (MACE) defined as: death, AMI, stroke, acute heart failure, re-CABG, re-PTCA;

  • major adverse coronary and cerebrovascular events during 1 year follow-up (MACCE): death, repeat revascularisation, AMI, unstable angina, heart transplantation, heart failure stroke;

  • long term survival;

  • severity of angina, exercise and functional capacity along with assessment of quality of life in one year observation.

Interventions

Percutaneous Coronary InterventionPROCEDURE
Coronary Artery Bypass GraftingPROCEDURE

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic coronary artery disease (angina CCS class 1)
  • left ventricle ejection fraction \<40%
  • coronary artery lesions suitable for percutaneous or surgical myocardial revascularisation
  • evidence for viability of the myocardium
  • written inform consent for the study

You may not qualify if:

  • age \<18 years
  • acute myocardial infarct with ST elevation within 30 days
  • concomitant congenital heart disease
  • mitral regurgitation required surgical intervention
  • history of bleeding diathesis, coagulopathy or abnormal bleeding within the previous 30 days.
  • major surgery within the previous 6 weeks
  • stroke or transient ischemic attack (TIA) within the previous 6 weeks
  • history of hemorrhagic stroke
  • uncontrolled hypertension
  • chronic renal insufficiency with creatinine \>2.0 mg/dl
  • platelet count \<100.000/mm3
  • hematocrit \<30%
  • PT \>1,2 times control
  • positive pregnancy test
  • any disease that may shorten the life expectancy of the patient
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University School of Silesia, 1-st Department of Cardiosurgery

Katowice, Silesian Voivodeship, 40-635, Poland

Location

University School of Silesia, 3-rd Department of Cardiology, Coronary Care Unit

Katowice, Silesian Voivodeship, 40-635, Poland

Location

Central Clinic Hospital

Warsaw, 02-507, Poland

Location

Military Clinic Hospital

Wroclaw, 50-981, Poland

Location

Related Publications (5)

  • Serruys PW, Ong AT, van Herwerden LA, Sousa JE, Jatene A, Bonnier JJ, Schonberger JP, Buller N, Bonser R, Disco C, Backx B, Hugenholtz PG, Firth BG, Unger F. Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial. J Am Coll Cardiol. 2005 Aug 16;46(4):575-81. doi: 10.1016/j.jacc.2004.12.082.

    PMID: 16098418RESULT

  • Scholz KH, Dubois-Rande JL, Urban P, Morice MC, Loisance D, Smalling RW, Figulla HR. Clinical experience with the percutaneous hemopump during high-risk coronary angioplasty. Am J Cardiol. 1998 Nov 1;82(9):1107-10, A6. doi: 10.1016/s0002-9149(98)00566-9.

    PMID: 9817489RESULT

  • Shawl FA, Quyyumi AA, Bajaj S, Hoff SB, Dougherty KG. Percutaneous cardiopulmonary bypass-supported coronary angioplasty in patients with unstable angina pectoris or myocardial infarction and a left ventricular ejection fraction < or = 25%. Am J Cardiol. 1996 Jan 1;77(1):14-9. doi: 10.1016/s0002-9149(97)89127-8.

    PMID: 8540450RESULT

  • Van Belle E, Blouard P, McFadden EP, Lablanche JM, Bauters C, Bertrand ME. Effects of stenting of recent or chronic coronary occlusions on late vessel patency and left ventricular function. Am J Cardiol. 1997 Nov 1;80(9):1150-4. doi: 10.1016/s0002-9149(97)00631-0.

    PMID: 9359541RESULT

  • Bax JJ, Poldermans D, Elhendy A, Cornel JH, Boersma E, Rambaldi R, Roelandt JR, Fioretti PM. Improvement of left ventricular ejection fraction, heart failure symptoms and prognosis after revascularization in patients with chronic coronary artery disease and viable myocardium detected by dobutamine stress echocardiography. J Am Coll Cardiol. 1999 Jul;34(1):163-9. doi: 10.1016/s0735-1097(99)00157-6.

    PMID: 10400006RESULT

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Percutaneous Coronary InterventionCoronary Artery Bypass

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresMyocardial RevascularizationCardiac Surgical ProceduresVascular GraftingThoracic Surgical Procedures

Study Officials

  • Pawel E Buszman, Prof

    3-rd Division of Cardiology, University School of Silesia, Poland

    STUDY DIRECTOR

  • Michal Tendera, Prof

    3-rd Division of Cardiology, University School of Silesia, Poland

    STUDY CHAIR

  • Andrzej Bochenek, Prof

    1-st Division of Cardiosurgery, University School of Silesia, Poland

    PRINCIPAL INVESTIGATOR

  • Robert J Gil, Prof

    Invasive Cardiology Department, Central Clinic Hospital, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

  • Piotr Ponikowski, Prof

    Heart Disease Department, Military Clinic Hospital, Wroclaw, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pawel E Buszman, Prof

CONTACT

+48 32 252 72 12pbuszman@ka.onet.pl

Iwona Szkrobka, MD

CONTACT

+48 602 457 602wilenka@wp.pl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 13, 2006

First Posted

October 16, 2006

Study Start

January 1, 2007

Study Completion

December 1, 2008

Last Updated

October 16, 2006

Record last verified: 2006-10

Locations

PL(4)