Correlation Between Coronary and Carotid Atherosclerotic Disease and Links With Clinical Outcomes

NCT02114541 | Completed

• 1 other identifier: CAIN-003_MHICC-31052012
• Study Type: observational
• Target: 1,339
• Locations: 5 countries
• Sites: 69

Brief Summary

The relationship of the natural history of atherosclerosis between different vascular beds has not been well characterized. Determination and comparison of the relative rates of progression and extents of atherosclerosis in the coronary and carotid arterial trees may have major impacts on clinical research and clinical practice. Correlation between findings in the carotid and coronary circulations is an important scientific and clinical topic to address. Results from a well design study incorporating imaging technologies that currently represent the gold standards for the assessment of coronary and carotid artery plaque burden, will have potentially impact on clinical research and clinical practice.

Conditions

Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Nominal change at follow-up from baseline in percent atheroma volume (PAV) obtained using intravascular ultrasound (IVUS)

  This endpoint will be the nominal change at follow-up from baseline in percent atheroma volume computed by dividing plaque volume by external elastic membrane volume and then multiplying by 100 at both time points, baseline and 2 year follow-up.

  Participants will have a baseline IVUS and a two year follow-up IVUS

Secondary Outcomes (5)

• plaque volume in target coronary artery

  change at 2 year follow-up from baseline

• change in plaque volume in the 5-mm sub-segment of target coronary artery

  change at 2 year follow-up from baseline

• Total vessel volume in the target coronary artery

  change at final 2 year follow-up from baseline

• change in coronary score assessed by quantitative coronary angiography

  change at final 2 year follow-up from baseline

• nominal change in carotid IMT(CIMT)

  change at final 2 year follow-up from baseline

Other Outcomes (1)

• clinical endpoints

  up to five year follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who were scheduled for clinically-indicated coronary angiography and undergone baseline coronary angiography and IVUS imaging data along with baseline carotid ultrasound imaging.

You may qualify if:

• Male and female patients over the age of 18 years.
• Patients scheduled for clinically indicated coronary angiography and possible ad hoc percutaneous coronary intervention (PCI) will be evaluated before their scheduled procedure.
• Written informed consent (approved by the Institutional Review Board \[IRB\]/Independent Ethics Committee \[IEC\]) obtained prior to any study specific procedures.
• Patients considered to be stable at enrollment (at the discretion of the investigator) are eligible provided they meet all other entry criteria.
• Entire Coronary Circulation: The patient must have angiographic evidence of coronary artery disease as defined by at least one lesion in any of the three major native coronary arteries that has \>20% reduction in lumen diameter by angiographic visual estimation or prior history of PCI. This vessel does not need to be the target coronary artery for IVUS. Any vessel with previous PCI may not be used as the target coronary artery.
• Left Main Coronary Artery: The patient must not have \> 50% reduction in lumen diameter by visual angiographic estimation.
• Target Coronary Artery: Patient will be required to have one "target" coronary artery for IVUS that has not undergone prior PCI, that is not a candidate to undergo PCI presently or in the next 24 months, and that has not been the cause of a recent myocardial infarction. The proximal 4 cm of the "target" artery in which
• IVUS examination will be performed at baseline:
• Must have a diameter stenosis \< 50% lumen diameter by visual assessment of the angiogram;
• Must have a reference diameter \> 2.5 mm;
• Must be free of filling defects suggestive of thrombus;
• Must not present any anatomical characteristic (such as but not limited to severe tortuosity or calcification) that would impede IVUS interrogation at baseline or follow-up
• Note: a lesion of up to 60% stenosis is permitted, distal to the target segment. A side branch of the target coronary artery for IVUS may not be a target for PCI.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for \>12 months) who refuse to undergo a urine or serum pregnancy test immediately prior to baseline and repeat imaging evaluations The urine or serum pregnancy test must be negative prior to imaging evaluations.
• Previous coronary artery bypass graft (CABG) surgery or probable need for CABG in the next 24 months.
• Patients who have symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] Class III or IV) at baseline.
• Patients with clinically significant valvular heart disease likely to require surgical repair or replacement during the treatment period of the study
• Any clinically significant medical condition or presence of any laboratory abnormality that is considered by the investigator to be clinically important and could interfere with the conduct of the study.
• The presence of severe liver disease as defined by the presence of cirrhosis, chronic active hepatitis, or chronic jaundice with hyperbilirubinemia,
• Patients with eGFR \< 45 ml/min prior to baseline imaging procedures, or with nephrotic syndrome
• Patients with a life expectancy less than 2 years.
• History of malignancy (except for curatively treated basal cell or squamous cell carcinoma of the skin) during the 3 years prior to the screening.
• Unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study.

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (69)

University of southern California

Los Angeles, California, 90033, United States

Location

Los Angeles Biomedical Research Institute at Harbor

Torrance, California, 90502, United States

Location

Jim Moran Heart and Vascular Research Institute, Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Florida Cardiovascular Research

Tampa, Florida, 33609, United States

Location

Emory University VA Medical Center

Decatur, Georgia, 30033, United States

Location

Norton Heart Specialist Springs

Louisville, Kentucky, 40205, United States

Location

John Hopkins University Office Capitol Region Research-CAPRES

Columbia, Maryland, 21044-2991, United States

Location

CV Research at MidMichigan Medical Center Midland

Midland, Michigan, 48670, United States

Location

Mercy Health Partners

Muskegon, Michigan, 49444, United States

Location

Cardiac and Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27599, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Parkway Cardiology associates

Oak Ridge, Tennessee, 37830, United States

Location

Dalla VAMC

Dallas, Texas, 75216, United States

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Mazankowski Alberta Heart Institute University Of Alberta Hospital ABACUS

Edmonton, Alberta, T6G 2B7, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W4, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Interventional Cardiology Research, St. Paul's Hospital

Vancouver, British Columbia, V6E 1M7, Canada

Location

Victoria Heart Institute Foundation (Office)/Royal Jubilee Hospital

Victoria, British Columbia, V8R 4R2, Canada

Location

Eastern Regional Health Authority

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Queen Elizabeth II - Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Cambridge Cardiac Care

Cambridge, Ontario, N1R 6V6, Canada

Location

McMaster Clinic Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

KMH Cardiology & Diagnostics Centre

Kitchener, Ontario, N2M 5N4, Canada

Location

University Hospital/LHSC

London, Ontario, N6A 5A5, Canada

Location

KMH Cardiology & Diagnostics Centre

Mississauga, Ontario, L5K 2L3, Canada

Location

York PCI Research

Newmarket, Ontario, L3Y 2P7, Canada

Location

Heart Care Research

Oshawa, Ontario, L1J 2J9, Canada

Location

Ottawa Civic Hospital / University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Scarborough Cardiology Research

Scarborough Village, Ontario, M1E 5E9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Complexe Hospitalier de la Sagamie

Chicoutimi, Quebec, G7H 5H6, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

CSSS-Hopital de Gatineau, secteur Hull

Gatineau, Quebec, J8Y 1W7, Canada

Location

Q & T Research

Gatineau, Quebec, J8Y 6S8, Canada

Location

Viacar Recherche Clinique

Greenfield Park, Quebec, J4V 2G8, Canada

Location

Cite de la Sante

Laval, Quebec, H7M 3L9, Canada

Location

CDRC Rive Sud

Longueuil, Quebec, J4M 2X1, Canada

Location

Foothills Medical Centre

Longueuil, Quebec, J4M 2X1, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1N6, Canada

Location

CHUM - Hopital Hotel-Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

CUSM Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Hopital Sacré-Cœur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Centre Hospitalier Régional de Lanaudière

Saint-Charles-Borromée, Quebec, J6E 6J2, Canada

Location

Centre de santé et des services sociaux de Beauce

Saint-Georges, Quebec, G5Y 4T8, Canada

Location

St-Jerome Medical Research Inc.

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

Sunnybrook Health Science Center

Toronto, Quebec, M4N 3M5, Canada

Location

Centre de santé et de services sociaux de Trois-Rivières

Trois-Rivières, Quebec, G9A 1Y1, Canada

Location

CSSS Vallée de l'Or

Val-d'Or, Quebec, J9P 3Y1, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N OW8, Canada

Location

Foothills Medical Centre

Calgary, T2N 2T9, Canada

Location

Universitatsklinikum Aachen

Aachen, 52074, Germany

Location

Klinikum Darmstadt

Darmstadt, 64283, Germany

Location

Universitat Heidelberg

Heidelberg, 69120, Germany

Location

Universitatsklinikum Ulm

Ulm, 89081, Germany

Location

Wojewodzki Szpital

Elblag, 82-300, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Oddzial Kliniczny Choroby

Krakow, 31-202, Poland

Location

Samodzielny Publiczny

Lublin, 20-954, Poland

Location

Szpital Kliniczny

Poznan, 61-848, Poland

Location

Klinika Kardiologii

Warsaw, 02-507, Poland

Location

Instytut Kardiologii

Warsaw, 4-628, Poland

Location

Woskowy Szpital Kliniczny

Wroclaw, 50-981, Poland

Location

Hopitaux Universitaire de Genève

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Jean-Claude Tardif, M.D

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: April 15, 2014
• Study Start: February 3, 2010
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2017
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

US (16); PL (8); DE (4); CH (1); CA (40)