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Clinical studies

ProbioHeart

Study : ProbioHeart
Study to Evaluate the Effects of Probiotics on the Glycemic Control in a Type 2 Diabetes Population.
ProbioHeart is a phase II study. The purpose of this project is to evaluate the effects of a probiotic supplement (Bio-K+50B®) versus placebo (an inactive pill) on blood sugar levels in adult type 2 diabetes patients and other blood measurements of inflammation and lipids (blood fats) such as cholesterol. This study will also evaluate the make-up of your gut bacteria, and other changes that may occur.

Principal Investigator: Dr. Jean-Claude Tardif

We are seeking participants:


• Men or Women ≥ 18 years;
• Diagnosed with type 2 diabetes;
• Having a suboptimal glycemic control as evidenced by HbA1c >7%;
• Currently not taking insulin.

Participation in this study involves:

• Duration of participation in the study is approximately 14 weeks;
• A minimum of 3 visits to the MHI and 2 follow up calls;
• Taking 2 capsules of the study product once a day at breakfast during 12 weeks;
• Blood samples will be taken at each of the 3 visits to the MHI;
• The participants will have to provide four fecal samples (these are self-collected at home according to instructions and are picked up by courrier to be sent to the lab. There is no direct handling of the samples);
• Participants will be asked to complete a daily diary in a check box format.


Study start date: 29th August 2017.

For additional information or to express your interest to participate in this study, please contact:
Study coordinators : Ms. Sarah Samson ou Ms. Cyntia Pennestri
Telephone : 514 376-3330, extension 2744 or 2236

dal-GenE

A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trial

Dal-GenE is a worldwide phase 3 study. The study aims to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in participants having recently been hospitalized for an acute coronary syndrome (heart attack or ischemia) and with the AA genetic variant in the ADCY9 gene.

Principal Investigator: Dr. Jean C. Grégoire

Study start date: March 15th, 2016.

Planned duration of participation in the study: From 2.5 to 5 years

We are seeking:

  • Men or Women ≥ 45 years; 
  • Participants having been hospitalized for an acute coronary syndrome within 4 to 12 weeks prior enrollment in the study;
  • Participants with the AA variant in the ADCY9 gene;
  • Participants who are not suffering from heart failure or liver disease.

Your participation entails:

During the study, participants will need to take 2 tablets of the study medication (dalcetrapib or placebo) once a day. They will be asked to come to the clinic every 6 months for a follow-up visit for approximately 2.5 to 5 years. Blood samples will be collected at the screening visit (to confirm the genetic profile inclusion criteria), at the randomization visit, as well as the 6 months visit. 

For additional information or to participate in this study, please contact :

Colette Morin at 514-376-3330 ext.3337


BRAIN-AF

The BRAIN-AF clinical study is conducted by a team of specialists and researchers from the Montreal Heart Institute (MHI) in collaboration with the Canadiean Stroke Prevention Intervention Network, the phamaceutical company Bayer, the Montreal Health Innovations Coordinating Center (MHICC) and the MHI Foundation.

The study, which is a world first, aims to demonstrate that taking low dose of rivaroxaban, an anticoagulant, could decrease the risk of developing cognitive impairment, transient ischemic attack or stroke in patients with atrial fibrillation. This clinical study was announced on november 19th 2015.

You whish to learn more about this study? View our French Virtual Conference. HERE

Participate in this clinical study:

The MHI BRAIN-AF team is currently seeking participants for this study. Patients under 60 years of age with atrial fibrillation are potentially admissible for this clinical study. If you would like to get further information or if you are interested in participating in this study, please contact:

Research coordinator :  Diane David
Telephone :    514-376-3330 poste 2884
E-mail: diane.david@icm-mhi.org

What does BRAIN-AF stand for?

BRAIN-AF is the acronym for Blended Randomized trial of Anticoagulation to prevent Ischemic stroke and Neurocognitive impairment in Atrial Fibrillation.

COLCOT

Colchicine Cardiovascular Outcomes Trial - COLCOT

COLCOT clinical trial is an international phase 3 study. This study will evaluate the impact of colchicine, a well-known anti-inflammatory drug used for hundreds of years for various conditions, on the reduction of cardiovascular events recurrence in patient recently diagnosed with myocardial infarction.

Principal Investigator: Dr Philippe L.-L'Allier

Participate in this clinical study:

We are seeking:

  • Men or women ≥18 years old.
  • Subjects who have suffered a heart attack within the last 30 days.
  • Subjects who have not undergone a coronary artery bypass graft in the last 3 years.
  • Subjects who are not suffering from inflammatory bowel diseases (Crohn’s disease or ulcerative colitis) or chronic diarrhea.
  • Subjects who are not currently taking colchicine for another indication.

Your participation entails:

For the duration of the trial, subjects will take the study medication (colchicine or placebo), one tablet once a day. Furthermore, they will have to attend 2 visits per year at the site. Subjects will also have a phone visit twice per year in between their in-person visit.

  • Study start date: October 15th 2015
  • Planned duration of participation in the study: Minimum of 2 years

Additional information:
If you would like to get further information or if you are interested in participating in this study, please contact:

Research coordinator:  Patricia Blaise
Telephone: 514-376-3330, extension 2740

ProbioHeart

Study : ProbioHeart
Study to Evaluate the Effects of Probiotics on the Glycemic Control in a Type 2 Diabetes Population.
ProbioHeart is a phase II study. The purpose of this project is to evaluate the effects of a probiotic supplement (Bio-K+50B®) versus placebo (an inactive pill) on blood sugar levels in adult type 2 diabetes patients and other blood measurements of inflammation and lipids (blood fats) such as cholesterol. This study will also evaluate the make-up of your gut bacteria, and other changes that may occur.

Principal Investigator: Dr. Jean-Claude Tardif

We are seeking participants:


• Men or Women ≥ 18 years;
• Diagnosed with type 2 diabetes;
• Having a suboptimal glycemic control as evidenced by HbA1c >7%;
• Currently not taking insulin.

Participation in this study involves:

• Duration of participation in the study is approximately 14 weeks;
• A minimum of 3 visits to the MHI and 2 follow up calls;
• Taking 2 capsules of the study product once a day at breakfast during 12 weeks;
• Blood samples will be taken at each of the 3 visits to the MHI;
• The participants will have to provide four fecal samples (these are self-collected at home according to instructions and are picked up by courrier to be sent to the lab. There is no direct handling of the samples);
• Participants will be asked to complete a daily diary in a check box format.


Study start date: 29th August 2017.

For additional information or to express your interest to participate in this study, please contact:
Study coordinators : Ms. Sarah Samson ou Ms. Cyntia Pennestri
Telephone : 514 376-3330, extension 2744 or 2236

dal-GenE

A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trial

Dal-GenE is a worldwide phase 3 study. The study aims to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in participants having recently been hospitalized for an acute coronary syndrome (heart attack or ischemia) and with the AA genetic variant in the ADCY9 gene.

Principal Investigator: Dr. Jean C. Grégoire

Study start date: March 15th, 2016.

Planned duration of participation in the study: From 2.5 to 5 years

We are seeking:

  • Men or Women ≥ 45 years; 
  • Participants having been hospitalized for an acute coronary syndrome within 4 to 12 weeks prior enrollment in the study;
  • Participants with the AA variant in the ADCY9 gene;
  • Participants who are not suffering from heart failure or liver disease.

Your participation entails:

During the study, participants will need to take 2 tablets of the study medication (dalcetrapib or placebo) once a day. They will be asked to come to the clinic every 6 months for a follow-up visit for approximately 2.5 to 5 years. Blood samples will be collected at the screening visit (to confirm the genetic profile inclusion criteria), at the randomization visit, as well as the 6 months visit. 

For additional information or to participate in this study, please contact :

Colette Morin at 514-376-3330 ext.3337


BRAIN-AF

The BRAIN-AF clinical study is conducted by a team of specialists and researchers from the Montreal Heart Institute (MHI) in collaboration with the Canadiean Stroke Prevention Intervention Network, the phamaceutical company Bayer, the Montreal Health Innovations Coordinating Center (MHICC) and the MHI Foundation.

The study, which is a world first, aims to demonstrate that taking low dose of rivaroxaban, an anticoagulant, could decrease the risk of developing cognitive impairment, transient ischemic attack or stroke in patients with atrial fibrillation. This clinical study was announced on november 19th 2015.

You whish to learn more about this study? View our French Virtual Conference. HERE

Participate in this clinical study:

The MHI BRAIN-AF team is currently seeking participants for this study. Patients under 60 years of age with atrial fibrillation are potentially admissible for this clinical study. If you would like to get further information or if you are interested in participating in this study, please contact:

Research coordinator :  Diane David
Telephone :    514-376-3330 poste 2884
E-mail: diane.david@icm-mhi.org

What does BRAIN-AF stand for?

BRAIN-AF is the acronym for Blended Randomized trial of Anticoagulation to prevent Ischemic stroke and Neurocognitive impairment in Atrial Fibrillation.

COLCOT

Colchicine Cardiovascular Outcomes Trial - COLCOT

COLCOT clinical trial is an international phase 3 study. This study will evaluate the impact of colchicine, a well-known anti-inflammatory drug used for hundreds of years for various conditions, on the reduction of cardiovascular events recurrence in patient recently diagnosed with myocardial infarction.

Principal Investigator: Dr Philippe L.-L'Allier

Participate in this clinical study:

We are seeking:

  • Men or women ≥18 years old.
  • Subjects who have suffered a heart attack within the last 30 days.
  • Subjects who have not undergone a coronary artery bypass graft in the last 3 years.
  • Subjects who are not suffering from inflammatory bowel diseases (Crohn’s disease or ulcerative colitis) or chronic diarrhea.
  • Subjects who are not currently taking colchicine for another indication.

Your participation entails:

For the duration of the trial, subjects will take the study medication (colchicine or placebo), one tablet once a day. Furthermore, they will have to attend 2 visits per year at the site. Subjects will also have a phone visit twice per year in between their in-person visit.

  • Study start date: October 15th 2015
  • Planned duration of participation in the study: Minimum of 2 years

Additional information:
If you would like to get further information or if you are interested in participating in this study, please contact:

Research coordinator:  Patricia Blaise
Telephone: 514-376-3330, extension 2740