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Vascular DiseaseNCT02114541

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

An observational study of Vascular Disease, run by Montreal Heart Institute at 69 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Vascular Disease
How many people
1,339 participants
Where
69 sitesin 5 countries
Study dates
3 Feb 2010to 12 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.
  • Angiographic inclusion 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

69 sites in 5 countries.

69 sites in 5 countries

Canada40 sites

  • Foothills Medical Centre

    Calgary, T2N 2T9

  • Cambridge Cardiac Care

    Cambridge, Ontario, N1R 6V6

  • Complexe Hospitalier de la Sagamie

    Chicoutimi, Quebec, G7H 5H6

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Mazankowski Alberta Heart Institute University Of Alberta Hospital ABACUS

    Edmonton, Alberta, T6G 2B7

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • CSSS-Hopital de Gatineau, secteur Hull

    Gatineau, Quebec, J8Y 1W7

  • Q & T Research

    Gatineau, Quebec, J8Y 6S8

  • Viacar Recherche Clinique

    Greenfield Park, Quebec, J4V 2G8

  • Queen Elizabeth II - Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • McMaster Clinic Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • KMH Cardiology & Diagnostics Centre

    Kitchener, Ontario, N2M 5N4

  • Cite de la Sante

    Laval, Quebec, H7M 3L9

  • University Hospital/LHSC

    London, Ontario, N6A 5A5

  • CDRC Rive Sud

    Longueuil, Quebec, J4M 2X1

  • Foothills Medical Centre

    Longueuil, Quebec, J4M 2X1

  • KMH Cardiology & Diagnostics Centre

    Mississauga, Ontario, L5K 2L3

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1N6

  • CHUM - Hopital Hotel-Dieu

    Montreal, Quebec, H2W 1T8

  • CUSM Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Hopital Sacré-Cœur de Montreal

    Montreal, Quebec, H4J 1C5

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W4

  • York PCI Research

    Newmarket, Ontario, L3Y 2P7

  • Heart Care Research

    Oshawa, Ontario, L1J 2J9

  • Ottawa Civic Hospital / University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec, Quebec, G1V 4G5

  • Centre Hospitalier Régional de Lanaudière

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • Centre de santé et des services sociaux de Beauce

    Saint-Georges, Quebec, G5Y 4T8

  • St-Jerome Medical Research Inc.

    Saint-Jérôme, Quebec, J7Z 5T3

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N OW8

  • Scarborough Cardiology Research

    Scarborough Village, Ontario, M1E 5E9

  • Eastern Regional Health Authority

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

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • University Health Network

    Toronto, Ontario, M5G 2C4

  • Sunnybrook Health Science Center

    Toronto, Quebec, M4N 3M5

  • Centre de santé et de services sociaux de Trois-Rivières

    Trois-Rivières, Quebec, G9A 1Y1

  • CSSS Vallée de l'Or

    Val-d'Or, Quebec, J9P 3Y1

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Interventional Cardiology Research, St. Paul's Hospital

    Vancouver, British Columbia, V6E 1M7

  • Victoria Heart Institute Foundation (Office)/Royal Jubilee Hospital

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

United States16 sites

  • University of North Carolina Hospital

    Chapel Hill, North Carolina, 27599

  • John Hopkins University Office Capitol Region Research-CAPRES

    Columbia, Maryland, 21044-2991

  • Dalla VAMC

    Dallas, Texas, 75216

  • Emory University VA Medical Center

    Decatur, Georgia, 30033

  • Jim Moran Heart and Vascular Research Institute, Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • University of southern California

    Los Angeles, California, 90033

  • Norton Heart Specialist Springs

    Louisville, Kentucky, 40205

  • CV Research at MidMichigan Medical Center Midland

    Midland, Michigan, 48670

  • Mercy Health Partners

    Muskegon, Michigan, 49444

  • Parkway Cardiology associates

    Oak Ridge, Tennessee, 37830

  • Cardiac and Vascular Research Center of Northern Michigan

    Petoskey, Michigan, 49770

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Florida Cardiovascular Research

    Tampa, Florida, 33609

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Los Angeles Biomedical Research Institute at Harbor

    Torrance, California, 90502

Other trials in United States

Poland8 sites

  • Wojewodzki Szpital

    Elblag, 82-300

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Oddzial Kliniczny Choroby

    Krakow, 31-202

  • Samodzielny Publiczny

    Lublin, 20-954

  • Szpital Kliniczny

    Poznan, 61-848

  • Klinika Kardiologii

    Warsaw, 02-507

  • Instytut Kardiologii

    Warsaw, 4-628

  • Woskowy Szpital Kliniczny

    Wroclaw, 50-981

Other trials in Poland

Germany4 sites

  • Universitatsklinikum Aachen

    Aachen, 52074

  • Klinikum Darmstadt

    Darmstadt, 64283

  • Universitat Heidelberg

    Heidelberg, 69120

  • Universitatsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Switzerland1 site

  • Hopitaux Universitaire de Genève

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: Global Observational Study to Evaluate the Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes

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.

Read the detailed description

The CAIN-003 study was a prospective observational multi-center imaging study of subjects scheduled for clinically-indicated coronary angiography. CAIN-003 provided for the collection of baseline coronary angiography and IVUS imaging data along with baseline carotid ultrasound imaging. CAIN-003 study participants underwent follow-up coronary and carotid imaging at 2-years, and were then contacted by phone on an annual basis for an additional 3 years for the collection of cardiovascular and cerebrovascular clinical endpoints.

MHICC-31052012 was a prospective, observational, multi-center study of subjects who had successfully undergone baseline imaging in the dal-PLAQUE 2 study (A multicenter, double-blind, randomized, placebo-controlled study, evaluating the effect of treatment with dalcetrapib 600 mg on atherosclerosis disease). The dal-PLAQUE 2 study, which provided for the collection of baseline and 2-year follow-up coronary angiography, coronary IVUS and carotid ultrasound imaging data, was terminated by the sponsor prior to completion due to the discontinuation of the dalcetrapib drug development program. The MHICC-31052012 study allowed for the collection of follow-up imaging and clinical endpoint data from subjects who had successfully undergone baseline IVUS imaging in dal-PLAQUE 2.

Data from CAIN-003 and MHICC-31052012 was pooled to support the objective of determining the correlation and clinical relevance of these imaging endpoints.

The objectives of the CAIN-003 and MHICC-31052012 study were:

  • To compare the extent of atherosclerosis present in the coronary vasculature with the extent of atherosclerosis present in the carotid vasculature at a single point in time.
  • To compare the associations of atherosclerosis burden with coronary risk factors in the coronary arteries and carotid arteries, in multivariable regression.
  • To compare the rate of atherosclerosis progression or regression in the coronary vasculature with the rate of atherosclerosis progression or regression in the carotid vasculature over a 2-year period.
  • To determine the correlation between imaging biomarkers and cardiovascular outcomes over a 5-year period.
Medical subject headings
Vascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. plaque volume in target coronary artery

    This secondary IVUS endpoint will include the nominal change in plaque volume in the target coronary artery, as well as the percent (relative) change in plaque volume.

    Measured: change at 2 year follow-up from baseline

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

    change in plaque volume in the 5-mm sub-segment with the greatest disease burden at baseline, and change in plaque volume in the 5-mm sub-segment with the smallest plaque area at baseline.

    Measured: change at 2 year follow-up from baseline

  3. Total vessel volume in the target coronary artery

    Total vessel volume for all anatomically comparable slices in the 30-mm target coronary artery segment and the change in plaque characterization indices.

    Measured: change at final 2 year follow-up from baseline

  4. change in coronary score assessed by quantitative coronary angiography

    Evaluation of change in coronary score assessed by quantitative coronary angiography and defined as the per-patient mean of the minimal lumen diameter for all lesions measured. As well evaluation of the cumulative coronary stenosis score (calculated by adding all percent diameter stenoses in standard international units).

    Measured: change at final 2 year follow-up from baseline

  5. nominal change in carotid IMT(CIMT)

    This secondary endpoint will be obtained using 2D B-mode carotid ultrasound and will be the nominal change at final follow-up from baseline in carotid IMT(CIMT), where CIMT is computed as the per scan average of the mean IMT values of carotid segments.

    Measured: change at final 2 year follow-up from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2014 (estimated)
  2. Study start3 Feb 2010
  3. Primary completion12 Dec 2017
  4. Study completion12 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,339 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02114541
Sponsor's protocol ID
CAIN-003_MHICC-31052012
Status last verified
Feb 2022
First submitted
18 Jul 2013
Last updated
9 Mar 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Disease, run by Montreal Heart Institute at 69 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Canada, United States, Poland, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nominal change at follow-up from baseline in percent atheroma volume (PAV) obtained using intravascular ultrasound (IVUS) (time frame: Participants will have a baseline IVUS and a two year follow-up IVUS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02114541.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.

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