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AtherosclerosisNCT01353612

Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes

An observational study of Atherosclerosis, run by Canadian Atherosclerosis Imaging Network at 39 sites in Canada.

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

This is a prospective, multi-center imaging study expecting to enroll approximately 1350 patients scheduled for clinically-indicated coronary angiography. Following informed consent, patient will undergo baseline coronary intravascular ultrasound (IVUS) imaging and non-invasive ultrasound imaging of their carotid… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerosis
How many people
1,626 participants
Where
39 sitesCanada
Study dates
Jan 2010to 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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with clinical indication for coronary angiography

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.
  • Angiogram meeting qualifying criteria

Who cannot join

  • 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,
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  • 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

39 sites in 1 country.

39 sites in 1 country

Canada39 sites

  • Foothills Medical Centre

    Calgary, British Columbia, 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

  • University of Alberta Hospital

    Edmonton, Alberta, T6L 5X8

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • CSSS-Hopital de Gatineau, secteur Hull

    Gatineau, Quebec, J8Y 6S9

  • 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

  • St-Mary's Hospital

    Kitchener, Ontario, N2M 1B2

  • KMH Cardiology & Diagnostics Centre

    Kitchener, Ontario, N2M 5N4

  • CSSS de Laval

    Laval, Quebec, H7M 3L9

  • London Health Sciences Center

    London, Ontario, N6G 2V2

  • Hopital Pierre Boucher

    Longueuil, Quebec, J4M 2X1

  • KMH Cardiology & Diagnostics Centre

    Mississauga, Ontario, L5K 2L3

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • CHUM Hopital-Hôtel-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

  • Southlake Regional Health Center

    Newmarket, Ontario, L3Y 2R2

  • Heart Care Research

    Oshawa, Ontario, L1J 2J9

  • 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

  • John Health Science Center

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

  • Sunnybrook Health Science Center

    Toronto, Ontario, M4N 3M5

  • University Health Network

    Toronto, Ontario, M5G 2C4

  • St. Michael's Hospital

    Toronto, Quebec, M5B 1W8

  • CHRTR de Trois-Rivières

    Trois-Rivières, Quebec, G8Z 3R9

  • 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, V6Z 1Y6

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

About this study

This is a prospective, multi-center imaging study expecting to enroll approximately 1350 patients scheduled for clinically-indicated coronary angiography. Following informed consent, patient will undergo baseline coronary intravascular ultrasound (IVUS) imaging and non-invasive ultrasound imaging of their carotid arteries. Following a 2-year follow-up period, patients will undergo repeat coronary IVUS and standard invasive coronary angiography as well as carotid ultrasound examination.

Additionally, patients will be contacted by phone on an annual basis for 5 years to collect cardiovascular and cerebrovascular clinical endpoints. Evaluations of plaque burden will be made using invasive and non invasive imaging tools in order to assess correlations between vascular beds, imaging technologies and main cardiovascular events.

Read the detailed description

CTA and PET Substudy:

A subset of patients enrolled into the main CAIN3 study will undergo a CTA. At sites where both CTA and PET imaging modalities exist, patients will be asked to undergo both tests. The CTA and PET scans can be done separately on 2 imaging beds on different days or performed on the same imaging bed, resulting in a combined CTA and PET scan being done in one scheduled visit. All imaging will be done within 90 days after the follow up IVUS.

The choice of radiotracer used (NaF or FDG) for PET imaging will be dependent upon site and availability on the day of the scan. A total of 120 patients will be enrolled in this substudy with approximately 50-60 undergoing CTA and PET.

Conditions
Atherosclerosis
Medical subject headings
Atherosclerosis

What is being measured

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

  1. co-primary outcome measure - Nominal change from baseline in percent atheroma volume

    intravascular ultrasound measure

    Measured: 2 years

  2. co-primary outcome measure - nominal change from baseline in carotid IMT

    2D B-mode carotid ultrasound measure

    Measured: 2 years

Secondary outcomes (1)

  1. cardiovascular morbidity and mortality

    as adjudicated by a Clinical Endpoint Committee

    Measured: 5 years

Timeline

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

  1. First posted13 May 2011 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2017
  4. Study completionDec 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
1,626 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01353612
Sponsor's protocol ID
CAIN-003
Status last verified
Feb 2020
First submitted
12 May 2011
Last updated
24 Feb 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis, run by Canadian Atherosclerosis Imaging Network at 39 sites in Canada.

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 5 inclusion and 10 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Canada. 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?

co-primary outcome measure - Nominal change from baseline in percent atheroma volume (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT01353612.

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 24 Feb 2020.

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