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NCT Number: NCT01727063

Cell Therapy in Severe Chronic Ischemic Heart Disease

Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization.

This study was designed to test the hypothesis that direct, intramyocardial injection of autologous bone marrow cells may further improve myocardial perfusion in patients undergoing incomplete bypass surgery.

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Key information

Conditions

Chronic Ischemic Heart Disease Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Heart Institute

São Paulo, 05403-000, Brazil

About this study

All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived cells (BMC) during surgery.

During follow-up, myocardial perfusion assessment will be performed to determine the improvement in treated areas compared to non-treated segments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptoms of angina or angina equivalent
  • documented coronary artery disease (invasive angiography)
  • documented myocardial ischemia (stress echo, cardiac scintigraphy, or MRI)
  • unsuitable for complete myocardial revascularization (PCI or CABG) OR even if a complete procedure in feasible, it is anticipated that myocardial perfusion may not be restored due to poor distal beds

Exclusion criteria

  • severe LV dysfunction (EF < 25% on echo)
  • short life expectacy (below < 1 year)
  • diagnosis of cancer in the past 5 years
  • diagnosis of hematological diseases
  • diagnosis of severe heart disease of other etiologies including valvular heart disease, Chagas' disease, etc)
  • diagnosis of acute coronary syndrome in the past 3 months
  • diagnosis of chronic kidney disease stage V requiring chronic dialysis

Treatment and study plan

Cell Therapy

Procedure

Intramyocardial injection of autologous bone marrow-derived cells

Primary outcomes

  1. Increase in myocardial perfusion

    Time frame: 1, 6 and 12 months

    Patients will undergo myocardial perfusion assessment by MRI during pharmacological stress with adenosine or dipyridamole. Alternatively, cardiac scintigraphy can be used in patients with contra-indications to MRI.

Secondary outcomes

  1. Improvement in LV function

    Time frame: 1, 6 and 12 months

    LV function (global and regional) will be assessed by MRI.

Other outcomes

  1. Improvement in angina functional class

    Time frame: 1, 6 and 12 months

    Angina functional class will be determined using the Canadian Cardiovascular Society classification.

Sponsors and collaborators

Lead sponsor

Ministry of Health, Brazil

Other Gov

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery

Acronym: MiHeart

Important dates

Study start
2006
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2012
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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